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More Diagnostics

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K072257 MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELLAS2008-01-30 View
510(k) K050125 RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4JJY2005-03-18 View
510(k) K982845 CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3JJT1998-08-21 View
510(k) K980331 IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\SDIF1998-03-16 View
510(k) K972976 CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVELJJT1997-08-29 View
510(k) K970778 LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4JJX1997-04-17 View
510(k) K946193 FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3GIL1995-08-24 View
510(k) K943571 MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTSDAP1995-06-15 View
510(k) K944999 SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3JJX1995-06-06 View
510(k) K941698 SERUM VOLATILES CONTROL - LEVELS 1 AND 2JJY1994-07-28 View
510(k) K941876 WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2JJY1994-07-28 View
510(k) K932657 FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2DAP1993-11-02 View
510(k) K932660 LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2JJX1993-10-28 View
510(k) K932658 CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3JJX1993-07-28 View
510(k) K932659 MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUMJJX1993-07-28 View
510(k) K932662 CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVELLAS1993-07-26 View
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