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 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K810355 | ALT (UV) TEST | Boehringer Mannheim Corp. | 1981-02-23 | Traditional | PDF ↗ |
| K801857 | DATA-ZYME LAT(GPT) PROCEDURE | Data Medical Associates, Inc. | 1980-09-16 | Traditional | PDF ↗ |
| K801119 | COBAS REAGENT FOR ALT (GPT) | Roche Analytical Instruments, Inc. | 1980-06-09 | Traditional | PDF ↗ |
| K800689 | REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- | Diagnostic Solutions, Inc. | 1980-05-30 | Traditional | PDF ↗ |
| K800115 | DURAZYME GPT/ALT | American Monitor Corp. | 1980-02-13 | Traditional | PDF ↗ |
| K800038 | ALT REAGENT | Gilford Diagnostics | 1980-01-21 | Traditional | PDF ↗ |
| K791641 | SGPT REAGENT SET MODIFICATION | American Monitor Corp. | 1979-09-24 | Traditional | PDF ↗ |
| K791083 | SPIN CHEM, DETERMINATION OF ALT (GPT) | Smithkline Diagnostics, Inc. | 1979-07-17 | Traditional | PDF ↗ |
| K791084 | PLUS CHEM, DETERMINATION OF ALT (GPT) | Smithkline Diagnostics, Inc. | 1979-07-17 | Traditional | PDF ↗ |
| K790522 | COULTER ACCU-ZYME II GPT REAGENT | Coulter Electronics, Inc. | 1979-05-01 | Traditional | PDF ↗ |
| K790016 | SERUM, GLUTAMIC-PYRUVIC | Fisher Scientific Co., LLC | 1979-02-15 | Traditional | PDF ↗ |
| K781726 | REAGENT SET, SGPT SERUM GLUTAMIC | Medical Analysis Systems, Inc. | 1978-11-03 | Traditional | PDF ↗ |
| K780791 | SGPT/ALT REAGENT SYSTEM | American Monitor Corp. | 1978-06-13 | Traditional | PDF ↗ |
| K780636 | SINGLE VIAL 10 SGPT-TRIS | Boehringer Mannheim Corp. | 1978-05-18 | Traditional | PDF ↗ |
| K780462 | ALT(GPT) UNI-UV, SGPT | Sclavo, Inc. | 1978-05-12 | Traditional | PDF ↗ |
| K780373 | STAC SYSTEM | Technicon Instruments Corp. | 1978-04-28 | Traditional | PDF ↗ |
| K780102 | ULTRAZYME PLUS GPT | Harleco | 1978-02-13 | Traditional | PDF ↗ |
| K780040 | ALANINE TRANSAMINASE | Beckman Instruments, Inc. | 1978-01-31 | Traditional | PDF ↗ |
| K772030 | GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT | Harleco | 1977-11-14 | Traditional | PDF ↗ |
| K771152 | DYNAZYME II GPT 340 | J.T. Baker Chemical Co. | 1977-11-03 | Traditional | PDF ↗ |
| K771466 | MULTISTAT III ALANINE AMINOTRANSFERASE | Instrumentation Laboratory CO | 1977-09-02 | Traditional | PDF ↗ |
| K771033 | SMAC SYS., SUPPLEMENTAL PRODUCTS FOR | Mid Tech, Inc. | 1977-08-04 | Traditional | PDF ↗ |
| K770991 | SERUM GLUTAMIC PYRUVIC TRANSAMINASE | Macomb Chemical Co. | 1977-08-02 | Traditional | PDF ↗ |
| K770882 | ULTRAZYME PLUS GPT | Harleco | 1977-07-14 | Traditional | PDF ↗ |
| K770314 | REAGENT GPT, ENZYME | Icn Pharmaceuticals, Inc. | 1977-03-30 | Traditional | PDF ↗ |
| K761269 | GEMENI GPT (ALT) ASSAY | Electro-Nucleonics Laboratories, Inc. | 1976-12-29 | Traditional | PDF ↗ |
| K760194 | NDC#12739-0010-1 C-ZYME GPT | Coulter Electronics, Inc. | 1976-08-03 | Traditional | PDF ↗ |
Product code CKA · Class I · Clinical Chemistry. Data: openFDA.