Product code CKA
- Device name
- Nadh Oxidation/Nad Reduction, Alt/Sgpt
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1030
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K120945 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 |
| K113382 | ACE ALT REAGENT | Alfa Wassermann | 2012-07-19 |
| K061020 | DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE | Dade Behring, Inc. | 2006-05-10 |
| K020487 | CARESIDE ALT | Careside, Inc. | 2002-06-04 |
| K980028 | ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Trace America, Inc. | 1998-02-02 |
| K973869 | TRACE REAGENT LINE FOR THE COBAS MIRA | Trace America, Inc. | 1998-01-07 |
| K974003 | ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 | Diagnostic Chemicals , Ltd. | 1997-12-05 |
| K971323 | ALT OR SGPT | Carolina Liquid Chemistries Corp. | 1997-04-21 |
| K965134 | ALT/SGPT | Derma Media Lab., Inc. | 1997-02-18 |
| K961123 | ALT INCORPORATING DST | Trace Scientific , Ltd. | 1996-04-25 |
| K952427 | CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE | Beckman Instruments, Inc. | 1995-09-21 |
| K952744 | ALANINE AMINOTRANSFERASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-07 |
| K951332 | PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT | Dade Intl., Inc. | 1995-06-19 |
| K951818 | HICHEM ALT REAGENT KIT | Hi Chem, Inc. | 1995-05-15 |
| K944080 | ALT QVET | Prisma Systems | 1994-11-22 |
| K941314 | STANBIO ALT/GPT (LUQUI-UV) TEST SET | Stanbio Laboratory | 1994-07-20 |
| K941497 | SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY | Solarcare, Inc. | 1994-05-24 |
| K941287 | LIQUID ALT(SGPT) REAGENT SET | Pointe Scientific, Inc., | 1994-05-03 |
| K935180 | ALANINE AMINOTRANSFERASE (ALT) TEST | Em Diagnostic Systems, Inc. | 1994-01-13 |
| K930070 | HEMOCARD HEMOGLOBIN E | Isolab, Inc. | 1993-04-08 |
| K925339 | OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT | Olympus Corp. | 1993-02-05 |
| K923510 | ALT (GPT) - ALANINE AMINOTRANSFERASE | Randox Laboratories, Ltd. | 1992-11-16 |
| K924245 | ROCHE REAGENT FOR ALT | Roche Diagnostic Systems, Inc. | 1992-10-22 |
| K923257 | EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000 | Em Diagnostic Systems, Inc. | 1992-09-28 |
| K923623 | IL TEST ALT, PN 35311 | Instrumentation Laboratory CO | 1992-09-17 |
| K922884 | OLYMPUS ALANINE AMINOTRANSFERASE REAGENT | Olympus Corp. | 1992-07-28 |
| K922109 | KING DIAGNOSTICS ALT (GPT) REAGENT | King Diagnostics, Inc. | 1992-06-04 |
| K921016 | SYNERMED ALT/GPT REAGENT KIT | Synermed, Inc. | 1992-05-07 |
| K920335 | MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD | Heraeus Kulzer, Inc. | 1992-03-24 |
| K914464 | ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43 | Em Diagnostic Systems, Inc. | 1991-11-22 |
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