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)
Top companies in CKA
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 23, 1981 | K810355 | ALT (UV) TEST Boehringer Mannheim Corp. | CKA |
| Sep 16, 1980 | K801857 | DATA-ZYME LAT(GPT) PROCEDURE Data Medical Associates, Inc. | CKA |
| Jun 9, 1980 | K801119 | COBAS REAGENT FOR ALT (GPT) Roche Analytical Instruments, Inc. | CKA |
| May 30, 1980 | K800689 | REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- Diagnostic Solutions, Inc. | CKA |
| Feb 13, 1980 | K800115 | DURAZYME GPT/ALT American Monitor Corp. | CKA |
| Jan 21, 1980 | K800038 | ALT REAGENT Gilford Diagnostics | CKA |
| Sep 24, 1979 | K791641 | SGPT REAGENT SET MODIFICATION American Monitor Corp. | CKA |
| Jul 17, 1979 | K791084 | PLUS CHEM, DETERMINATION OF ALT (GPT) Smithkline Diagnostics, Inc. | CKA |
| Jul 17, 1979 | K791083 | SPIN CHEM, DETERMINATION OF ALT (GPT) Smithkline Diagnostics, Inc. | CKA |
| May 1, 1979 | K790522 | COULTER ACCU-ZYME II GPT REAGENT Coulter Electronics, Inc. | CKA |
| Feb 15, 1979 | K790016 | SERUM, GLUTAMIC-PYRUVIC Fisher Scientific Co., LLC | CKA |
| Nov 3, 1978 | K781726 | REAGENT SET, SGPT SERUM GLUTAMIC Medical Analysis Systems, Inc. | CKA |
| Jun 13, 1978 | K780791 | SGPT/ALT REAGENT SYSTEM American Monitor Corp. | CKA |
| May 18, 1978 | K780636 | SINGLE VIAL 10 SGPT-TRIS Boehringer Mannheim Corp. | CKA |
| May 12, 1978 | K780462 | ALT(GPT) UNI-UV, SGPT Sclavo, Inc. | CKA |
| Apr 28, 1978 | K780373 | STAC SYSTEM Technicon Instruments Corp. | CKA |
| Feb 13, 1978 | K780102 | ULTRAZYME PLUS GPT Harleco | CKA |
| Jan 31, 1978 | K780040 | ALANINE TRANSAMINASE Beckman Instruments, Inc. | CKA |
| Nov 14, 1977 | K772030 | GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT Harleco | CKA |
| Nov 3, 1977 | K771152 | DYNAZYME II GPT 340 J.T. Baker Chemical Co. | CKA |
| Sep 2, 1977 | K771466 | MULTISTAT III ALANINE AMINOTRANSFERASE Instrumentation Laboratory CO | CKA |
| Aug 4, 1977 | K771033 | SMAC SYS., SUPPLEMENTAL PRODUCTS FOR Mid Tech, Inc. | CKA |
| Aug 2, 1977 | K770991 | SERUM GLUTAMIC PYRUVIC TRANSAMINASE Macomb Chemical Co. | CKA |
| Jul 14, 1977 | K770882 | ULTRAZYME PLUS GPT Harleco | CKA |
| Mar 30, 1977 | K770314 | REAGENT GPT, ENZYME Icn Pharmaceuticals, Inc. | CKA |
| Dec 29, 1976 | K761269 | GEMENI GPT (ALT) ASSAY Electro-Nucleonics Laboratories, Inc. | CKA |
| Aug 3, 1976 | K760194 | NDC#12739-0010-1 C-ZYME GPT Coulter Electronics, Inc. | CKA |
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