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 Nov 16, 1999

QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3

K993715

Seracare Technology

Immunology · 13d

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 Aug 21, 1998

CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3

K982845

More Diagnostics

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 Nov 06, 1997

DADE TRU-LIQUID CARDIAC CONTROL

K973974

Dade Intl., Inc.

Chemistry · 17d

Cleared Aug 29, 1997

CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL

K972976

More Diagnostics

Chemistry · 18d

Cleared Jul 25, 1997

CARDIAC STATUS CONTROLS

K972408

Spectral Diagnostics, Inc.

Chemistry · 29d

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 Feb 06, 1997

STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)

K965169

Specialized Assays, Inc.

Chemistry · 44d

Cleared Feb 04, 1997

STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)

K965166

Specialized Assays, Inc.

Chemistry · 42d

Cleared Feb 04, 1997

STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002)

K965168

Specialized Assays, Inc.

Chemistry · 42d

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