FDA Product Code
FDA Product Code CKA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1030
510(k) Clearances — 127 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K120945 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 | Traditional | PDF ↗ |
| K113382 | ACE ALT REAGENT | Alfa Wassermann | 2012-07-19 | Traditional | PDF ↗ |
| K061020 | DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE | Dade Behring, Inc. | 2006-05-10 | Special | PDF ↗ |
| K020487 | CARESIDE ALT | Careside, Inc. | 2002-06-04 | Traditional | PDF ↗ |
| K980028 | ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Trace America, Inc. | 1998-02-02 | Traditional | PDF ↗ |
| K973869 | TRACE REAGENT LINE FOR THE COBAS MIRA | Trace America, Inc. | 1998-01-07 | Traditional | PDF ↗ |
| K974003 | ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 | Diagnostic Chemicals , Ltd. | 1997-12-05 | Traditional | PDF ↗ |
| K971323 | ALT OR SGPT | Carolina Liquid Chemistries Corp. | 1997-04-21 | Traditional | PDF ↗ |
| K965134 | ALT/SGPT | Derma Media Lab., Inc. | 1997-02-18 | Traditional | PDF ↗ |
| K961123 | ALT INCORPORATING DST | Trace Scientific , Ltd. | 1996-04-25 | Traditional | PDF ↗ |
| K952427 | CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE | Beckman Instruments, Inc. | 1995-09-21 | Traditional | PDF ↗ |
| K952744 | ALANINE AMINOTRANSFERASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-07 | Traditional | PDF ↗ |
| K951332 | PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT | Dade Intl., Inc. | 1995-06-19 | Traditional | PDF ↗ |
| K951818 | HICHEM ALT REAGENT KIT | Hi Chem, Inc. | 1995-05-15 | Traditional | PDF ↗ |
| K944080 | ALT QVET | Prisma Systems | 1994-11-22 | Traditional | PDF ↗ |
| K941314 | STANBIO ALT/GPT (LUQUI-UV) TEST SET | Stanbio Laboratory | 1994-07-20 | Traditional | PDF ↗ |
| K941497 | SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY | Solarcare, Inc. | 1994-05-24 | Traditional | PDF ↗ |
| K941287 | LIQUID ALT(SGPT) REAGENT SET | Pointe Scientific, Inc., | 1994-05-03 | Traditional | PDF ↗ |
| K935180 | ALANINE AMINOTRANSFERASE (ALT) TEST | Em Diagnostic Systems, Inc. | 1994-01-13 | Traditional | PDF ↗ |
| K930070 | HEMOCARD HEMOGLOBIN E | Isolab, Inc. | 1993-04-08 | Traditional | PDF ↗ |
| K925339 | OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT | Olympus Corp. | 1993-02-05 | Traditional | PDF ↗ |
| K923510 | ALT (GPT) - ALANINE AMINOTRANSFERASE | Randox Laboratories, Ltd. | 1992-11-16 | Traditional | PDF ↗ |
| K924245 | ROCHE REAGENT FOR ALT | Roche Diagnostic Systems, Inc. | 1992-10-22 | Traditional | PDF ↗ |
| K923257 | EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000 | Em Diagnostic Systems, Inc. | 1992-09-28 | Traditional | PDF ↗ |
| K923623 | IL TEST ALT, PN 35311 | Instrumentation Laboratory CO | 1992-09-17 | Traditional | PDF ↗ |
| K922884 | OLYMPUS ALANINE AMINOTRANSFERASE REAGENT | Olympus Corp. | 1992-07-28 | Traditional | PDF ↗ |
| K922109 | KING DIAGNOSTICS ALT (GPT) REAGENT | King Diagnostics, Inc. | 1992-06-04 | Traditional | PDF ↗ |
| K921016 | SYNERMED ALT/GPT REAGENT KIT | Synermed, Inc. | 1992-05-07 | Traditional | PDF ↗ |
| K920335 | MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD | Heraeus Kulzer, Inc. | 1992-03-24 | Traditional | PDF ↗ |
| K914464 | ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43 | Em Diagnostic Systems, Inc. | 1991-11-22 | Traditional | PDF ↗ |
| K913846 | ABBOTT QUICKSTART ALANINE AMINOTRANSFER | Em Diagnostic Systems, Inc. | 1991-09-19 | Traditional | PDF ↗ |
| K905767 | COULTER DART ALT (GPT) REAGENT | Coulter Electronics, Inc. | 1991-01-25 | Traditional | PDF ↗ |
| K903198 | ALANINE AMINOTRANSFERASE TEST | Em Diagnostic Systems, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K901702 | NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522 | American Research Products Co. | 1990-04-25 | Traditional | PDF ↗ |
| K900905 | TECHNICON AXON SYSTEM REAGENT METHODS | Technicon Instruments Corp. | 1990-04-03 | Traditional | PDF ↗ |
| K901105 | PARAMAX ALANINE AMINOTRANSFERASE REAGENT | Baxter Healthcare Corp | 1990-03-23 | Traditional | PDF ↗ |
| K897163 | COULTER ALT (GPT) REAGENT | Coulter Electronics, Inc. | 1990-03-09 | Traditional | PDF ↗ |
| K896234 | COBAS READY STAT PROFILE REAGENT STRIP | Roche Diagnostic Systems, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K896001 | ALANINE AMINOTRANSFERASE (ALT) | American Monitor Corp. | 1989-11-13 | Traditional | PDF ↗ |
| K892930 | TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES | Technicon Instruments Corp. | 1989-07-27 | Traditional | PDF ↗ |
| K893752 | ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403 | Em Diagnostic Systems, Inc. | 1989-07-20 | Traditional | PDF ↗ |
| K893560 | ALT REAGENT (PROCEDURE NUMBER 159) | Sigma Chemical Co. | 1989-07-20 | Traditional | PDF ↗ |
| K890698 | ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55) | Abbott Laboratories | 1989-04-10 | Traditional | PDF ↗ |
| K891469 | ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT | Trace Scientific , Ltd. | 1989-04-04 | Traditional | PDF ↗ |
| K885144 | CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN | Heraeus Kulzer, Inc. | 1989-02-02 | Traditional | PDF ↗ |
| K884376 | ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652 | Em Diagnostic Systems, Inc. | 1989-01-11 | Traditional | PDF ↗ |
| K884936 | ALANINE AMINOTRANSFERASE | Catachem, Inc. | 1989-01-03 | Traditional | PDF ↗ |
| K883181 | SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE | Beckman Instruments, Inc. | 1988-09-19 | Traditional | PDF ↗ |
| K883205 | ALTLTS ALANINE AMINO TRANSFERASE ALT | Electro-Nucleonics, Inc. | 1988-09-09 | Traditional | PDF ↗ |
| K875079 | MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE | Miles Laboratories, Inc. | 1988-04-05 | Traditional | PDF ↗ |
| K880275 | ALT (SGPT) REAGENT SET | Tech-Neal Scientific, Inc. | 1988-03-01 | Traditional | PDF ↗ |
| K874835 | PYRIDOXAL-5-PHOSPHATE TABLETS | Boehringer Mannheim Corp. | 1988-01-21 | Traditional | PDF ↗ |
| K874586 | EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017 | Em Diagnostic Systems, Inc. | 1988-01-21 | Traditional | PDF ↗ |
| K872483 | MODIFIED ALT (GPT) REAGENT | Trace Scientific , Ltd. | 1987-08-19 | Traditional | PDF ↗ |
| K872830 | BIOTROL ALT/TGP MONOREACTIF | Biotrol, USA, Inc. | 1987-08-13 | Traditional | PDF ↗ |
| K871782 | ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT) | Biochemical Trade, Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K870879 | ALANINE TRANSAMINASE (ALT) TEST KIT | Genetic Systems Corp. | 1987-03-19 | Traditional | PDF ↗ |
| K870086 | ALANINE AMINOTRANSFERASE (ALT)/(GPT) | Catachem, Inc. | 1987-03-06 | Traditional | PDF ↗ |
| K864850 | WAKO(TM) AUTOKIT GPT | Wako Chemicals USA, Inc. | 1987-01-09 | Traditional | PDF ↗ |
| K864906 | ALANINE AMINO TRANSFERASE ALT/SGPT | Tech-Co, Inc. | 1986-12-31 | Traditional | PDF ↗ |
| K864335 | WAKO GPT II - HA | Wako Chemicals USA, Inc. | 1986-12-16 | Traditional | PDF ↗ |
| K863053 | ALT S.C.E. (GPT) | J. D. Assoc. | 1986-12-10 | Traditional | PDF ↗ |
| K863962 | EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95 | Em Diagnostic Systems, Inc. | 1986-11-28 | Traditional | PDF ↗ |
| K863253 | ALT/GPT PROCEDURE | Data Medical Associates, Inc. | 1986-09-16 | Traditional | PDF ↗ |
| K862833 | MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT | Diagnostic Chemicals, Ltd. (Usa) | 1986-08-19 | Traditional | PDF ↗ |
| K861792 | TWIN GOT-AST IFCC/GPT-ALT IFCC | Boehringer Mannheim Corp. | 1986-07-29 | Traditional | PDF ↗ |
| K862209 | ALT (SGPT) REAGENT SET (UV RATE) | Sterling Diagnostics, Inc. | 1986-06-25 | Traditional | PDF ↗ |
| K861366 | ALT-30, 60 AND 100 | Dimension Diagnostics | 1986-06-25 | Traditional | PDF ↗ |
| K861658 | ALT/GPT PROCEDURE | Data Medical Associates, Inc. | 1986-05-29 | Traditional | PDF ↗ |
| K861231 | ALT REAGENT CARTRIDGE (PRODUCT NO. 88210) | Hi Chem, Inc. | 1986-04-28 | Traditional | PDF ↗ |
| K861002 | VISION SGPT (ALT) | Abbott Laboratories | 1986-04-21 | Traditional | PDF ↗ |
| K860727 | ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT | Trace Scientific , Ltd. | 1986-04-07 | Traditional | PDF ↗ |
| K860110 | GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET | Technostics Intl. | 1986-02-11 | Traditional | PDF ↗ |
| K854186 | IN VITRO TEST DETERMINATION OF SGPT(ALT) | Clinical Data, Inc. | 1985-12-25 | Traditional | PDF ↗ |
| K854502 | ALT(OPTIMIZED) REAGENT | Sigma Diagnostics, Inc. | 1985-11-25 | Traditional | PDF ↗ |
| K852867 | HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE | Hi Chem, Inc. | 1985-08-29 | Traditional | PDF ↗ |
| K851995 | ALT (ALANINE AMINO-THRANSFERASE)REAGENT | Alpkem Corp. | 1985-05-30 | Traditional | PDF ↗ |
| K851923 | AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE | Amresco, Inc. | 1985-05-24 | Traditional | PDF ↗ |
| K844251 | ALT/GPT REAGENT SET | Sterling Biochemical, Inc. | 1985-01-08 | Traditional | PDF ↗ |
| K843111 | ROCHE REAGENT FOR ALT | Roche Diagnostic Systems, Inc. | 1984-10-05 | Traditional | PDF ↗ |
| K843334 | SYSTEMATE GPT 67209 | Em Diagnostic Systems, Inc. | 1984-09-20 | Traditional | PDF ↗ |
| K842564 | SIGMA 59-UV FOR ALANINE AMINOTRANSFER | Sigma Chemical Co. | 1984-08-12 | Traditional | PDF ↗ |
| K842241 | ALANINE AMINOTRANSFERASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-07-18 | Traditional | PDF ↗ |
| K841060 | SGPT REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K840705 | PARAMAX ALANINE AMINOTRANSFERASE | American Dade | 1984-03-09 | Traditional | PDF ↗ |
| K832639 | ALT -LTS | Electro-Nucleonics Laboratories, Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K830959 | FLOW-PAC SGPT REAGENT | Amresco, Inc. | 1983-05-04 | Traditional | PDF ↗ |
| K822494 | OPTIMIZED UV-GPT REAGENT SET | Biorent Diagnostic, Inc. | 1982-09-21 | Traditional | PDF ↗ |
| K821206 | SGPT-UV REAGENT SET | Omega Medical Electronics | 1982-07-22 | Traditional | PDF ↗ |
| K821946 | ALT ENZYME ASSAY KIT | Travenol Laboratories, S.A. | 1982-07-20 | Traditional | PDF ↗ |
| K821882 | ULTRAZYME PLUS GPT | Harleco Diagnostics | 1982-07-14 | Traditional | PDF ↗ |
| K821805 | PYRIDOXAL-5-PHOSPHATE STRIPES | Boehringer Mannheim Corp. | 1982-07-02 | Traditional | PDF ↗ |
| K821536 | DOWFLOW ALT-UV DETERMINATION | The Dow Chemical Co. | 1982-06-14 | Traditional | PDF ↗ |
| K821048 | LIQUID-STAT TM AST-UV LIQUID ENZUNE | Beckman Instruments, Inc. | 1982-05-03 | Traditional | PDF ↗ |
| K820525 | RAICHEM GPT (ALT) REAGENT | Reagents Applications, Inc. | 1982-03-15 | Traditional | PDF ↗ |
| K820394 | TECHNICON RA-1000 SYSTEM ADD. ANALYT | Technicon Instruments Corp. | 1982-03-08 | Traditional | PDF ↗ |
| K813495 | ALT (SGPT) | Pointe Scientific, Inc., | 1981-12-31 | Traditional | PDF ↗ |
| K812926 | ALT-QUANTICHROM | Abbott Laboratories | 1981-11-06 | Traditional | PDF ↗ |
| K812591 | ULTRA ZYME PLUS GPT, #64956, 65035 & 36 | Harleco | 1981-09-24 | Traditional | PDF ↗ |
| K811694 | CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT | Baker Instructions Corp. | 1981-07-01 | Traditional | PDF ↗ |
Product code CKA · Class I · Clinical Chemistry. Data: openFDA.