Company
Heritage Labs International LLC
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
59recalls (0 in 12 months)
38recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2013 | Heritage Labs International LLC Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 dif Terminated |
KST | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs Blood/Urine Collection Kit, Product A1100, packed in bags in bulk, 25 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood Terminated |
JKA | K883787 |
| Jan 11, 2012 | Heritage Labs International LLC Principal Combo Test Pak, Product K8700, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise DBS Test Pak/HW-Kronos KROJI, Product K8603, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Biometric Combo Test Kit, Product K8500, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and Terminated |
JKA | K993787 |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs University of Michigan Clinical Kit, Product K8311, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specime Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC University of Mannheim DBS Collection Kit, Product K8308, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collec Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Principal Waist Circumference DBS Collection Kit, Product K8307, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC University of Michigan DBS Collection Kit, Product K8306, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collect Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC H & W Principal DBS Collection Kit, Product K8305, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection sup Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs Appraise DBS Bio Disk Test, Product K8304-QNS, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen coll Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC HooperHolmes Health & Wellness, Product K8303, each kit packed in an envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise DBS Kit, Product K8302, each kit packed in a bag or envelope. (This kit was previously Product A1773, which is listed separately due to the new part number.) Each kit contains 1 Triad Mediu Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise DBS Test Pak/Moore Medical LLC, Product K8301, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen colle Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise/Heritage Combo A1C & Blood Test Kit, Product K8300, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise/Heritage Combo Kit, Product K8100, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection suppli Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC NDI/Life Extension Microtainer Blood Kit, Product K7625, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen coll Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC NDI Combo Test Pak Omega 3, Product K7618, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplie Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC NDI Combo Test Pak Omega 3, Product K7616, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplie Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Appraise A1c Retail Kit, Product K7615, each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and i Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs Nutrasource NDI (USA) DBS Kit, Product K7610, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen c Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs Appraise A1c Diabetes Home Test , Product K7609, 24 kits/shipping carton (Product K7609), each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 507 Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs Appraise Diabetes A1c Test , 24 kits/shipping carton (Product K7604), each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and bloo Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Reli On Hemoglobin A1c Test (Replacement), Product K7603, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen col Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs Appraise Diabetes A1c Test , 12 kits/shipping carton (Product K7602), each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and bloo Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise Hemoglobin A1c Test , Product K7600, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection sup Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise A1C Test Pak Kit (Carolina Care Plan), Product K7400, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specim Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise A1C Test Pak Kit (Alere), Product K7300, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise A1C Test Pak Kit (IBM Care Advantage), Product K7200, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specim Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise A1C Test Pak Kit (Consumers Life Insurance Company), Product K7100, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, an Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise A1C (Retail) Collection Kit, Product K7050, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collect Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise A1C Test Pak Kit (Medical Mutual of Ohio), Product K7000, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood sp Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Alere Blood Collection Kit (Carolina Care Plan), Product K6900, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood speci Terminated |
LCP | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Alere Blood Collection Kit (Consumer Life Insurance), Product K6700, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Medical Mutual Blood Collection Kit, Product K6500, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collecti Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Nationwide DBS Collection Kit, Product K4003, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection sup Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Appraise DBS Kit, Product K4002, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, Terminated |
LCP | K990899 |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs Yale Research Kit, Product A2364, 50 kits/shipping carton, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and bl Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC The National Children's Study Child Hair Kit/Heritage Labs Westat Child Hair Kit, Product A2362, each kit packed in a bag or envelope and contains 2 Triad Medium Alcohol Prep Pads, Cat. No. 10-3001, Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC The National Children's Study Adult Blood Birth Mother Kit/Heritage Labs Westat Birth Blood Mother Kit, Product A2357, Kit #BA0121221, each kit packed in a bag or envelope, 25 kits/shipping carton, a Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC AGLH - Lung Health Study, Saliva & Finger Stick Supplemental Kit, Product A2352, each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and subassembly collection packs Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC AGLH - Lung Health Study, Specimen Collection & Return Kit, Phlebotomy & Urine Kit, Product A2351, 10 kits/shipping carton, each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 507 Terminated |
JKA | K993787 |
| Jan 11, 2012 | Heritage Labs International LLC The National Children's Study Adult Nail Collection Kit/Heritage Labs Westat Adult Nail Collection Kit, Product A2250, Kit #BJ0136829, and Training Kit, Product A2250T, Kit #TJ0000001, each kit packe Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC The National Children's Study Adult Hair Collection Kit/Heritage Labs Westat Adult Hair Collection Kit, Product A2225, Kit #BL1301873, and Training Kit, Product A2225T, Kit #TL0000001, each kit packed Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC The National Children's Study Adult Blood T1 Father Kit/Heritage Labs Westat T1 Father Blood Kit, Product A2020, Kit #BA4373185, each kit packed in a bag or envelope, 25 kits/shipping carton, and cont Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC The National Children's Study Adult Blood T3 Mother Kit/Heritage Labs Westat T3 Mother Blood Kit, Product A2015, Kit #BA0146946, each kit packed in a bag or envelope, 25 kits/shipping carton, and cont Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC The National Children's Study Adult Blood T1 Mother Kit/Heritage Labs Westat T1 Mother Blood Kit, Product A2010, Kit #BA0057371, and Training Kit, A2010T, Kit #TA0000151, each kit packed in a bag or e Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC The National Children's Study Adult Blood P1 Mother Kit, Product A2000, Kit #BB5649523, and A2000T (for training), kit #TA0001801, each kit packed in a bag or envelope, 25 kits/shipping carton, each k Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Bravo Wellness Kit, Product A1778, each kit packed in a bag or envelope. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies, a Terminated |
JKA | K993787 |
| Jan 11, 2012 | Heritage Labs International LLC Rules Based Medicine blood collection kit, Product A1777, each kit packed in a box, 12 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, an Terminated |
KDT | None listed |
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