Atlas FDA

Biosite Inc

11 FDA 510(k) clearances · Recalling firm

Sort:Newest firstOldest first

◉ Watch Biosite Inc

RecordFirmDate
Triage Total Controls 5, Level 1: Five 0.25 mL tubes. Storage Temp <-20C. Intended use: As recall (Z-1788-2010)Biosite Inc2010-06-11
Triage Total Controls 5, Level 2: Five 0.25 mL tubes. Storage Temp <-20C. Intended use: As recall (Z-1789-2010)Biosite Inc2010-06-11
Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each of five dif recall (Z-1790-2010)Biosite Inc2010-06-11
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Cod recall (Z-0006-2010)Biosite Inc2009-10-06
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subs recall (Z-0007-2010)Biosite Inc2009-10-06
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Code recall (Z-0008-2010)Biosite Inc2009-10-06
Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Cod recall (Z-0009-2010)Biosite Inc2009-10-06
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subs recall (Z-0010-2010)Biosite Inc2009-10-06
Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in a recall (Z-1391-2009)Biosite Inc2009-05-08
Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for the recall (Z-1088-2009)Biosite Inc2009-03-17
Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPO recall (Z-1352-2008)Biosite Inc2008-03-27

Track Biosite Inc automatically

Every clearance here is in the API, with alerts when new ones post.