FDA Product Code JJT: Enzyme Controls (assayed And Unassayed)

Cleared Oct 03, 2006

MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER

K062751

Quantimetrix Corp.

Chemistry · 19d

Cleared Mar 21, 2003

CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL

K030768

Cliniqa Corporation

Chemistry · 10d

Cleared Jan 24, 2003

ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3

K030102

Bayer Healthcare, LLC

Chemistry · 14d

Cleared May 24, 2002

LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL

K021498

Bio-Rad

Chemistry · 15d

Cleared Sep 06, 2001

LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648

K012656

Bio-Rad

Chemistry · 24d

Cleared Nov 23, 1999

CARDIASURE CARDIAC MARKERS CONTROL

K993723

Quantimetrix Corp.

Chemistry · 20d

Cleared Aug 30, 1999

CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3

K992430

Medical Analysis Systems, Inc.

Toxicology · 40d

Cleared Feb 02, 1999

QUANTEX ASO-CRP-RP CONTROL II

K984437

Instrumentation Laboratory CO

Chemistry · 50d

Cleared Dec 09, 1998

CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3

K984277

Medical Analysis Systems, Inc.

Chemistry · 9d

Cleared Feb 25, 1998

LIQUICHEK CARDIAC MARKERS CONTROL LT

K980556

Bio-Rad

Chemistry · 12d

Cleared Dec 10, 1997

TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL

K974461

Biosite Incorporated

Chemistry · 15d

Cleared May 27, 1997

QUANTEX ASO-CRP-RF CONTROL

K971777

Instrumentation Laboratory CO

Chemistry · 13d

Cleared Apr 08, 1997

CARDIOISOZYME, CK/LD ISOENZYME CONTROL

K970856

Medical Analysis Systems, Inc.

Chemistry · 29d

Cleared Jun 11, 1996

LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688)

K961828

Bio-Rad

Chemistry · 29d

Cleared Apr 25, 1996

OPUS CK-MB & TOTAL CK CONTROLS

K960275

Behring Diagnostics, Inc.

Chemistry · 97d

Cleared Apr 23, 1996

LIQUID CARDIAC MARKER 1,2,3 ASSAYED

K960246

Ciba Corning Diagnostics Corp.

Chemistry · 98d

Cleared Sep 21, 1995

ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE

K950803

Isolab, Inc.

Chemistry · 212d

Cleared Apr 20, 1995

QUANTITATE ENZYME VERIFIER SET

K951293

Beckman Instruments, Inc.

Chemistry · 29d

Cleared Mar 30, 1995

CARDIO REP LD CONTROL - CAT NO. 3325

K950801

Helena Laboratories

Chemistry · 37d

Cleared Oct 04, 1994

HICHEM ENZYME VERIFIER KIT

K943684

Hi Chem, Inc.

Chemistry · 67d

Cleared Oct 28, 1993

CARDIO REP RECOMBINANT CK ABNORMAL CONTROL

K932442

Helena Laboratories

Chemistry · 161d

Cleared Jul 06, 1993

ROCHE CARDIOTROL-CK

K930889

Roche Diagnostic Systems, Inc.

Chemistry · 134d

Cleared Dec 17, 1992

LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3

K925151

Bio-Rad

Chemistry · 65d

Cleared Aug 23, 1990

LIQUICHEK CK/LD ISOENZYME CONTROL

K903430

Bio-Rad

Chemistry · 23d