ClearanceBrief
Panels › Clinical Chemistry › Product code CKA · Class 1

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Regulation 862.1030

0510(k)s in 12 months (127 all time)
0recalls in 12 months (18 all time)
10recalls that name a 510(k)
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Top companies in CKA

Company510(k)sRecalls
Em Diagnostic Systems, Inc.100
Pointe Scientific, Inc.,28
Abbott Laboratories34
Boehringer Mannheim Corp.50
American Monitor Corp.40
Beckman Instruments, Inc.40
Coulter Electronics, Inc.40
Harleco40
Technicon Instruments Corp.40
Trace Scientific , Ltd.40
Decided510(k)Device and applicantCode
Jun 7, 2013K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
Hitachi Chemical Diagnostics, Inc.
CKA
Jul 19, 2012K113382ACE ALT REAGENT
Alfa Wassermann
CKA
May 10, 2006K061020DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
Dade Behring, Inc.
CKA
Jun 4, 2002K020487CARESIDE ALT
Careside, Inc.
CKA
Feb 2, 1998K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
Trace America, Inc.
CKA
Jan 7, 1998K973869TRACE REAGENT LINE FOR THE COBAS MIRA
Trace America, Inc.
CKA
Dec 5, 1997K974003ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30
Diagnostic Chemicals , Ltd., CA
CKA
Apr 21, 1997K971323ALT OR SGPT
Carolina Liquid Chemistries Corp.
CKA
Feb 18, 1997K965134ALT/SGPT
Derma Media Lab., Inc.
CKA
Apr 25, 1996K961123ALT INCORPORATING DST
Trace Scientific , Ltd.
CKA
Sep 21, 1995K952427CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE
Beckman Instruments, Inc.
CKA
Aug 7, 1995K952744ALANINE AMINOTRANSFERASE REAGENT SYSTEM
Medical Diagnostic Technologies, Inc.
CKA
Jun 19, 1995K951332PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT
Dade Intl., Inc.
CKA
May 15, 1995K951818HICHEM ALT REAGENT KIT
Hi Chem, Inc.
CKA
Nov 22, 1994K944080ALT QVET
Prisma Systems
CKA
Jul 20, 1994K941314STANBIO ALT/GPT (LUQUI-UV) TEST SET
Stanbio Laboratory
CKA
May 24, 1994K941497SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY
Solarcare, Inc.
CKA
May 3, 1994K941287LIQUID ALT(SGPT) REAGENT SET
Pointe Scientific, Inc.,
CKA
Jan 13, 1994K935180ALANINE AMINOTRANSFERASE (ALT) TEST
Em Diagnostic Systems, Inc.
CKA
Apr 8, 1993K930070HEMOCARD HEMOGLOBIN E
Isolab, Inc.
CKA
Feb 5, 1993K925339OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT
Olympus Corp.
CKA
Nov 16, 1992K923510ALT (GPT) - ALANINE AMINOTRANSFERASE
Randox Laboratories, Ltd., IR
CKA
Oct 22, 1992K924245ROCHE REAGENT FOR ALT
Roche Diagnostic Systems, Inc.
CKA
Sep 28, 1992K923257EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000
Em Diagnostic Systems, Inc.
CKA
Sep 17, 1992K923623IL TEST ALT, PN 35311
Instrumentation Laboratory CO
CKA
Jul 28, 1992K922884OLYMPUS ALANINE AMINOTRANSFERASE REAGENT
Olympus Corp.
CKA
Jun 4, 1992K922109KING DIAGNOSTICS ALT (GPT) REAGENT
King Diagnostics, Inc.
CKA
May 7, 1992K921016SYNERMED ALT/GPT REAGENT KIT
Synermed, Inc., CA
CKA
Mar 24, 1992K920335MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD
Heraeus Kulzer, Inc.
CKA
Nov 22, 1991K914464ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43
Em Diagnostic Systems, Inc.
CKA
Sep 19, 1991K913846ABBOTT QUICKSTART ALANINE AMINOTRANSFER
Em Diagnostic Systems, Inc.
CKA
Jan 25, 1991K905767COULTER DART ALT (GPT) REAGENT
Coulter Electronics, Inc.
CKA
Sep 12, 1990K903198ALANINE AMINOTRANSFERASE TEST
Em Diagnostic Systems, Inc.
CKA
Apr 25, 1990K901702NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522
American Research Products Co.
CKA
Apr 3, 1990K900905TECHNICON AXON SYSTEM REAGENT METHODS
Technicon Instruments Corp.
CKA
Mar 23, 1990K901105PARAMAX ALANINE AMINOTRANSFERASE REAGENT
Baxter Healthcare Corp
CKA
Mar 9, 1990K897163COULTER ALT (GPT) REAGENT
Coulter Electronics, Inc.
CKA
Feb 16, 1990K896234COBAS READY STAT PROFILE REAGENT STRIP
Roche Diagnostic Systems, Inc.
CKA
Nov 13, 1989K896001ALANINE AMINOTRANSFERASE (ALT)
American Monitor Corp.
CKA
Jul 27, 1989K892930TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES
Technicon Instruments Corp.
CKA
Jul 20, 1989K893752ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403
Em Diagnostic Systems, Inc.
CKA
Jul 20, 1989K893560ALT REAGENT (PROCEDURE NUMBER 159)
Sigma Chemical Co.
CKA
Apr 10, 1989K890698ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55)
Abbott Laboratories
CKA
Apr 4, 1989K891469ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT
Trace Scientific , Ltd., AU
CKA
Feb 2, 1989K885144CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN
Heraeus Kulzer, Inc.
CKA
Jan 11, 1989K884376ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652
Em Diagnostic Systems, Inc.
CKA
Jan 3, 1989K884936ALANINE AMINOTRANSFERASE
Catachem, Inc.
CKA
Sep 19, 1988K883181SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE
Beckman Instruments, Inc.
CKA
Sep 9, 1988K883205ALTLTS ALANINE AMINO TRANSFERASE ALT
Electro-Nucleonics, Inc.
CKA
Apr 5, 1988K875079MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE
Miles Laboratories, Inc.
CKA

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