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Roche Diagnostics Corp.

FDA 510(k) & PMA Approved Devices — 263 products

Total Devices263
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K130138 SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMNBW2013-03-15 View
510(k) K101365 ELECSYS CA 19-9 CALCHECK 5JJX2010-10-05 View
510(k) K100853 COBAS 8000 MODULAR SERIES ANALYZERDCF2010-09-09 View
510(k) K101196 ACCU-CHEK ULTRFLEX INFUSION SETFPA2010-08-27 View
510(k) K093664 AMPHETAMINES II ASSAYDKZ2010-07-28 View
510(k) K101075 ELECSYS INSULIN CALCHECK 5JJX2010-06-11 View
510(k) K093421 ELECSYS TESTOSTERONE II IMMUNOASSAYCDZ2010-04-23 View
510(k) K092848 ELECSYS TROPONIN T CALCHECK 5JJX2010-03-19 View
510(k) K092940 COAGUCHEK XS PLUS PST SYSTEMGJS2010-03-05 View
510(k) K093700 ELECSYS HCG STAT CALCHECK 5JJX2010-03-04 View
510(k) K092649 ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190NBC2010-02-04 View
510(k) K083764 AMPHETAMINES IIDKZ2010-02-03 View
510(k) K092888 ELECSYS TOXO IGG CALCHECK 5JJX2009-11-10 View
510(k) K091601 ELECYS ANTI-CCP CALCHECKJJX2009-09-25 View
510(k) K082340 ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYSCGN2009-06-19 View
510(k) K083444 C-REACTIVE PROTEIN (LATEX)DCN2009-03-18 View
510(k) K072617 ELECSYS RUBELLA IGG IMMUNOASSAYLFX2008-12-05 View
510(k) K080092 ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROABJZO2008-07-28 View
510(k) K080811 TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SETNDY2008-06-20 View
510(k) K073501 ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGGLGD2008-06-09 View
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