Atlas FDA

HEMOCHEK-A1C SAMPLE COLLECTION KIT

FDA 510(k) clearance K990899 · decided 1999-12-21

Clearance details

K-number
K990899
Device name
HEMOCHEK-A1C SAMPLE COLLECTION KIT
Applicant
Osborn Group, Inc.
Decision
Substantially Equivalent
Date received
1999-03-18
Decision date
1999-12-21
Days to decision
278 days
Clearance type
Traditional
Product code
LCP
Device class
2
Regulation number
864.7470
Medical specialty
Hematology
Advisory committee
Hematology
Location
Olathe, KS, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Heritage Labs DBS/Urine Collection Kit, Product A1101, packed in bags in bulk, 25 kits/shi recall (Z-0525-2012)Heritage Labs International LLC2012-01-11
Heritage Labs Wellness Single Kit/Bulk, Product A1751, each kit packed in a bag or envelop recall (Z-0528-2012)Heritage Labs International LLC2012-01-11
Heritage Labs Wellness Kits w/Purple Top, Product A1767, each kit packed in a bag or envel recall (Z-0529-2012)Heritage Labs International LLC2012-01-11
Heritage Labs Wellness Kits, Product A1768, each kit packed in a bag or envelope in bulk, recall (Z-0530-2012)Heritage Labs International LLC2012-01-11
Heritage Labs Wellness Kits, Product A1769, each kit packed in a bag or envelope in bulk, recall (Z-0531-2012)Heritage Labs International LLC2012-01-11
Super Valu (Appraise) Combo Kit, Product A1773, each kit packed in a bag or envelope. (Thi recall (Z-0532-2012)Heritage Labs International LLC2012-01-11
Appraise DBS Kit, Product K4002, each kit packed in a bag or envelope and contains 1 Triad recall (Z-0547-2012)Heritage Labs International LLC2012-01-11
Nationwide DBS Collection Kit, Product K4003, each kit packed in a bag or envelope and con recall (Z-0548-2012)Heritage Labs International LLC2012-01-11
Alere Blood Collection Kit (Consumer Life Insurance), Product K6700, each kit packed in a recall (Z-0550-2012)Heritage Labs International LLC2012-01-11
Appraise A1C Test Pak Kit (Medical Mutual of Ohio), Product K7000, each kit packed in a ba recall (Z-0552-2012)Heritage Labs International LLC2012-01-11
Appraise A1C (Retail) Collection Kit, Product K7050, each kit packed in a bag or envelope recall (Z-0553-2012)Heritage Labs International LLC2012-01-11
Appraise A1C Test Pak Kit (Consumers Life Insurance Company), Product K7100, each kit pack recall (Z-0554-2012)Heritage Labs International LLC2012-01-11
Appraise A1C Test Pak Kit (IBM Care Advantage), Product K7200, each kit packed in a bag or recall (Z-0555-2012)Heritage Labs International LLC2012-01-11
Appraise A1C Test Pak Kit (Alere), Product K7300, each kit packed in a bag or envelope and recall (Z-0556-2012)Heritage Labs International LLC2012-01-11
Appraise A1C Test Pak Kit (Carolina Care Plan), Product K7400, each kit packed in a bag or recall (Z-0557-2012)Heritage Labs International LLC2012-01-11
Appraise Hemoglobin A1c Test , Product K7600, each kit packed in a bag or envelope and con recall (Z-0558-2012)Heritage Labs International LLC2012-01-11
Heritage Labs Appraise Diabetes A1c Test , 12 kits/shipping carton (Product K7602), each k recall (Z-0559-2012)Heritage Labs International LLC2012-01-11
Reli On Hemoglobin A1c Test (Replacement), Product K7603, each kit packed in a bag or enve recall (Z-0560-2012)Heritage Labs International LLC2012-01-11
Heritage Labs Appraise Diabetes A1c Test , 24 kits/shipping carton (Product K7604), each k recall (Z-0561-2012)Heritage Labs International LLC2012-01-11
Heritage Labs Appraise A1c Diabetes Home Test , Product K7609, 24 kits/shipping carton (Pr recall (Z-0562-2012)Heritage Labs International LLC2012-01-11
Appraise A1c Retail Kit, Product K7615, each kit packed in a box and contains 1 Triad Medi recall (Z-0564-2012)Heritage Labs International LLC2012-01-11
Appraise/Heritage Combo Kit, Product K8100, each kit packed in a bag or envelope and conta recall (Z-0568-2012)Heritage Labs International LLC2012-01-11
Appraise/Heritage Combo A1C & Blood Test Kit, Product K8300, each kit packed in a bag or e recall (Z-0569-2012)Heritage Labs International LLC2012-01-11
Appraise DBS Test Pak/Moore Medical LLC, Product K8301, each kit packed in a bag or envelo recall (Z-0570-2012)Heritage Labs International LLC2012-01-11
Appraise DBS Kit, Product K8302, each kit packed in a bag or envelope. (This kit was previ recall (Z-0571-2012)Heritage Labs International LLC2012-01-11
HooperHolmes Health & Wellness, Product K8303, each kit packed in an envelope and contains recall (Z-0572-2012)Heritage Labs International LLC2012-01-11
Heritage Labs Appraise DBS Bio Disk Test, Product K8304-QNS, each kit packed in a bag or e recall (Z-0573-2012)Heritage Labs International LLC2012-01-11
H & W Principal DBS Collection Kit, Product K8305, each kit packed in a bag or envelope an recall (Z-0574-2012)Heritage Labs International LLC2012-01-11
University of Michigan DBS Collection Kit, Product K8306, each kit packed in a bag or enve recall (Z-0575-2012)Heritage Labs International LLC2012-01-11
Principal Waist Circumference DBS Collection Kit, Product K8307, each kit packed in a bag recall (Z-0576-2012)Heritage Labs International LLC2012-01-11
University of Mannheim DBS Collection Kit, Product K8308, each kit packed in a bag or enve recall (Z-0577-2012)Heritage Labs International LLC2012-01-11
Heritage Labs University of Michigan Clinical Kit, Product K8311, each kit packed in a bag recall (Z-0578-2012)Heritage Labs International LLC2012-01-11
Appraise DBS Test Pak/HW-Kronos KROJI, Product K8603, each kit packed in a bag or envelope recall (Z-0580-2012)Heritage Labs International LLC2012-01-11
Principal Combo Test Pak, Product K8700, each kit packed in a bag or envelope and contains recall (Z-0581-2012)Heritage Labs International LLC2012-01-11