Atlas FDA

CKA

127 FDA 510(k) clearances · Product code

41 daysmedian time to decision
102 days90th percentile
127clearances measured

FDA profile

Official device name
Nadh Oxidation/Nad Reduction, Alt/Sgpt
Device class
Class I (low risk)
Regulation
21 CFR 862.1030
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2004: 1 · 2010: 8 · 2011: 39 · 2012: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST (K120945)Hitachi Chemical Diagnostics, Inc.2013-06-07
ACE ALT REAGENT (K113382)Alfa Wassermann2012-07-19
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE (K061020)Dade Behring, Inc.2006-05-10
CARESIDE ALT (K020487)Careside, Inc.2002-06-04
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K980028)Trace America, Inc.1998-02-02
TRACE REAGENT LINE FOR THE COBAS MIRA (K973869)Trace America, Inc.1998-01-07
ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 (K974003)Diagnostic Chemicals , Ltd.1997-12-05
ALT OR SGPT (K971323)Carolina Liquid Chemistries Corp.1997-04-21
ALT/SGPT (K965134)Derma Media Lab., Inc.1997-02-18
ALT INCORPORATING DST (K961123)Trace Scientific , Ltd.1996-04-25
CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE (K952427)Beckman Instruments, Inc.1995-09-21
ALANINE AMINOTRANSFERASE REAGENT SYSTEM (K952744)Medical Diagnostic Technologies, Inc.1995-08-07
PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT (K951332)Dade Intl., Inc.1995-06-19
HICHEM ALT REAGENT KIT (K951818)Hi Chem, Inc.1995-05-15
ALT QVET (K944080)Prisma Systems1994-11-22
STANBIO ALT/GPT (LUQUI-UV) TEST SET (K941314)Stanbio Laboratory1994-07-20
SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY (K941497)Solarcare, Inc.1994-05-24
LIQUID ALT(SGPT) REAGENT SET (K941287)Pointe Scientific, Inc.,1994-05-03
ALANINE AMINOTRANSFERASE (ALT) TEST (K935180)Em Diagnostic Systems, Inc.1994-01-13
HEMOCARD HEMOGLOBIN E (K930070)Isolab, Inc.1993-04-08
OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT (K925339)Olympus Corp.1993-02-05
ALT (GPT) - ALANINE AMINOTRANSFERASE (K923510)Randox Laboratories, Ltd.1992-11-16
ROCHE REAGENT FOR ALT (K924245)Roche Diagnostic Systems, Inc.1992-10-22
EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000 (K923257)Em Diagnostic Systems, Inc.1992-09-28
IL TEST ALT, PN 35311 (K923623)Instrumentation Laboratory CO1992-09-17
OLYMPUS ALANINE AMINOTRANSFERASE REAGENT (K922884)Olympus Corp.1992-07-28
KING DIAGNOSTICS ALT (GPT) REAGENT (K922109)King Diagnostics, Inc.1992-06-04
SYNERMED ALT/GPT REAGENT KIT (K921016)Synermed, Inc.1992-05-07
MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD (K920335)Heraeus Kulzer, Inc.1992-03-24
ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43 (K914464)Em Diagnostic Systems, Inc.1991-11-22
ABBOTT QUICKSTART ALANINE AMINOTRANSFER (K913846)Em Diagnostic Systems, Inc.1991-09-19
COULTER DART ALT (GPT) REAGENT (K905767)Coulter Electronics, Inc.1991-01-25
ALANINE AMINOTRANSFERASE TEST (K903198)Em Diagnostic Systems, Inc.1990-09-12
NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522 (K901702)American Research Products Co.1990-04-25
TECHNICON AXON SYSTEM REAGENT METHODS (K900905)Technicon Instruments Corp.1990-04-03
PARAMAX ALANINE AMINOTRANSFERASE REAGENT (K901105)Baxter Healthcare Corp1990-03-23
COULTER ALT (GPT) REAGENT (K897163)Coulter Electronics, Inc.1990-03-09
COBAS READY STAT PROFILE REAGENT STRIP (K896234)Roche Diagnostic Systems, Inc.1990-02-16
ALANINE AMINOTRANSFERASE (ALT) (K896001)American Monitor Corp.1989-11-13
TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES (K892930)Technicon Instruments Corp.1989-07-27
ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403 (K893752)Em Diagnostic Systems, Inc.1989-07-20
ALT REAGENT (PROCEDURE NUMBER 159) (K893560)Sigma Chemical Co.1989-07-20
ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55) (K890698)Abbott Laboratories1989-04-10
ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT (K891469)Trace Scientific , Ltd.1989-04-04
CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN (K885144)Heraeus Kulzer, Inc.1989-02-02
ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652 (K884376)Em Diagnostic Systems, Inc.1989-01-11
ALANINE AMINOTRANSFERASE (K884936)Catachem, Inc.1989-01-03
SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE (K883181)Beckman Instruments, Inc.1988-09-19
ALTLTS ALANINE AMINO TRANSFERASE ALT (K883205)Electro-Nucleonics, Inc.1988-09-09
MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE (K875079)Miles Laboratories, Inc.1988-04-05
ALT (SGPT) REAGENT SET (K880275)Tech-Neal Scientific, Inc.1988-03-01
PYRIDOXAL-5-PHOSPHATE TABLETS (K874835)Boehringer Mannheim Corp.1988-01-21
EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017 (K874586)Em Diagnostic Systems, Inc.1988-01-21
MODIFIED ALT (GPT) REAGENT (K872483)Trace Scientific , Ltd.1987-08-19
BIOTROL ALT/TGP MONOREACTIF (K872830)Biotrol, USA, Inc.1987-08-13
ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT) (K871782)Biochemical Trade, Inc.1987-05-26
ALANINE TRANSAMINASE (ALT) TEST KIT (K870879)Genetic Systems Corp.1987-03-19
ALANINE AMINOTRANSFERASE (ALT)/(GPT) (K870086)Catachem, Inc.1987-03-06
WAKO(TM) AUTOKIT GPT (K864850)Wako Chemicals USA, Inc.1987-01-09
ALANINE AMINO TRANSFERASE ALT/SGPT (K864906)Tech-Co, Inc.1986-12-31
WAKO GPT II - HA (K864335)Wako Chemicals USA, Inc.1986-12-16
ALT S.C.E. (GPT) (K863053)J. D. Assoc.1986-12-10
EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95 (K863962)Em Diagnostic Systems, Inc.1986-11-28
ALT/GPT PROCEDURE (K863253)Data Medical Associates, Inc.1986-09-16
MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT (K862833)Diagnostic Chemicals, Ltd. (Usa)1986-08-19
TWIN GOT-AST IFCC/GPT-ALT IFCC (K861792)Boehringer Mannheim Corp.1986-07-29
ALT (SGPT) REAGENT SET (UV RATE) (K862209)Sterling Diagnostics, Inc.1986-06-25
ALT-30, 60 AND 100 (K861366)Dimension Diagnostics1986-06-25
ALT/GPT PROCEDURE (K861658)Data Medical Associates, Inc.1986-05-29
ALT REAGENT CARTRIDGE (PRODUCT NO. 88210) (K861231)Hi Chem, Inc.1986-04-28
VISION SGPT (ALT) (K861002)Abbott Laboratories1986-04-21
ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT (K860727)Trace Scientific , Ltd.1986-04-07
GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET (K860110)Technostics Intl.1986-02-11
IN VITRO TEST DETERMINATION OF SGPT(ALT) (K854186)Clinical Data, Inc.1985-12-25
ALT(OPTIMIZED) REAGENT (K854502)Sigma Diagnostics, Inc.1985-11-25
HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE (K852867)Hi Chem, Inc.1985-08-29
ALT (ALANINE AMINO-THRANSFERASE)REAGENT (K851995)Alpkem Corp.1985-05-30
AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE (K851923)Amresco, Inc.1985-05-24
ALT/GPT REAGENT SET (K844251)Sterling Biochemical, Inc.1985-01-08
ROCHE REAGENT FOR ALT (K843111)Roche Diagnostic Systems, Inc.1984-10-05
SYSTEMATE GPT 67209 (K843334)Em Diagnostic Systems, Inc.1984-09-20
SIGMA 59-UV FOR ALANINE AMINOTRANSFER (K842564)Sigma Chemical Co.1984-08-12
ALANINE AMINOTRANSFERASE ASSAY KIT (K842241)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
SGPT REAGENT SET (K841060)Medical Specialties, Inc.1984-05-01
PARAMAX ALANINE AMINOTRANSFERASE (K840705)American Dade1984-03-09
ALT -LTS (K832639)Electro-Nucleonics Laboratories, Inc.1983-09-12
FLOW-PAC SGPT REAGENT (K830959)Amresco, Inc.1983-05-04
OPTIMIZED UV-GPT REAGENT SET (K822494)Biorent Diagnostic, Inc.1982-09-21
SGPT-UV REAGENT SET (K821206)Omega Medical Electronics1982-07-22
ALT ENZYME ASSAY KIT (K821946)Travenol Laboratories, S.A.1982-07-20
ULTRAZYME PLUS GPT (K821882)Harleco Diagnostics1982-07-14
PYRIDOXAL-5-PHOSPHATE STRIPES (K821805)Boehringer Mannheim Corp.1982-07-02
DOWFLOW ALT-UV DETERMINATION (K821536)The Dow Chemical Co.1982-06-14
LIQUID-STAT TM AST-UV LIQUID ENZUNE (K821048)Beckman Instruments, Inc.1982-05-03
RAICHEM GPT (ALT) REAGENT (K820525)Reagents Applications, Inc.1982-03-15
TECHNICON RA-1000 SYSTEM ADD. ANALYT (K820394)Technicon Instruments Corp.1982-03-08
ALT (SGPT) (K813495)Pointe Scientific, Inc.,1981-12-31
ALT-QUANTICHROM (K812926)Abbott Laboratories1981-11-06
ULTRA ZYME PLUS GPT, #64956, 65035 & 36 (K812591)Harleco1981-09-24
CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT (K811694)Baker Instructions Corp.1981-07-01
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