ClearanceBrief
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

CodeDeviceRecords
LCPAssay, Glycosylated Hemoglobin37
KDTContainer, Specimen Mailer And Storage, Sterile17
JKATubes, Vials, Systems, Serum Separators, Blood Collection4
KSTSystem, Blood Collection, Vacuum-Assisted, Manual1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Apr 18, 2013Heritage 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
KSTNone listed
Jan 11, 2012Heritage 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
JKAK883787
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
JKAK993787
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
KDTNone listed
Jan 11, 2012Heritage 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
KDTNone listed
Jan 11, 2012Heritage 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
KDTNone listed
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
KDTNone listed
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPNone listed
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
KDTNone listed
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
LCPK990899
Jan 11, 2012Heritage 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
KDTNone listed
Jan 11, 2012Heritage 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
KDTNone listed
Jan 11, 2012Heritage 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
KDTNone listed
Jan 11, 2012Heritage 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
KDTNone listed
Jan 11, 2012Heritage 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
JKAK993787
Jan 11, 2012Heritage 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
KDTNone listed
Jan 11, 2012Heritage 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
KDTNone listed
Jan 11, 2012Heritage 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
KDTNone listed
Jan 11, 2012Heritage 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
KDTNone listed
Jan 11, 2012Heritage 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
KDTNone listed
Jan 11, 2012Heritage 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
KDTNone listed
Jan 11, 2012Heritage 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
JKAK993787
Jan 11, 2012Heritage 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
KDTNone listed

Newest 50 of 59.

Get alerts for these product codes