510(k) K990899 ยท LCP Assay, Glycosylated Hemoglobin
HEMOCHEK-A1C SAMPLE COLLECTION KIT
| Applicant | Osborn Group, Inc., Olathe KS, US |
| Decision | Substantially Equivalent, Dec 21, 1999 |
| Received | Mar 18, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990899
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs DBS/Urine Collection Kit, Product A1101, 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 sp Terminated |
LCP | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs Wellness Single Kit/Bulk, Product A1751, each kit packed in a bag or envelope in bulk, 50 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC Terminated |
LCP | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs Wellness Kits w/Purple Top, Product A1767, each kit packed in a bag or envelope in bulk, 50 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, ND Terminated |
LCP | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs Wellness Kits, Product A1768, each kit packed in a bag or envelope in bulk, 25 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001- Terminated |
LCP | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs Wellness Kits, Product A1769, each kit packed in a bag or envelope in bulk, 50 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001- Terminated |
LCP | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Super Valu (Appraise) Combo Kit, Product A1773, each kit packed in a bag or envelope. (This kit has since changed to product A8302, which will be listed separately due to the new part number.) Each Terminated |
LCP | None listed |
| 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 | 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 | 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | 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 | 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
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