Panels › Clinical Chemistry › Product code CKD · Class 1
Hydrazone Colorimetry, Alt/Sgpt
Regulation 862.1030
0510(k)s in 12 months (11 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in CKD
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 9, 1999 | K991834 | CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 Cholestech Corp. | CKD |
| May 16, 1995 | K941192 | ORTHO ALT MICROWELL TEST SYSTEM Ortho Diagnostic Systems, Inc. | CKD |
| Feb 16, 1990 | K896237 | COBAS READY ALT REAGENT Roche Diagnostic Systems, Inc. | CKD |
| Dec 29, 1988 | K884784 | VIRGO(R) MICROWELL ALT ASSAY Electro-Nucleonics, Inc. | CKD |
| Oct 13, 1988 | K883387 | ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) Tech-Co, Inc. | CKD |
| Dec 4, 1986 | K864082 | REFLOTRON(R) ALT (GPT) Boehringer Mannheim Corp. | CKD |
| Apr 3, 1986 | K860485 | SGPT (ALT) REAGENT SET (COLORIMETRIC) Sterling Diagnostics, Inc. | CKD |
| Nov 27, 1984 | K844283 | SGPT REAGENT SET Livonia Diagnostics, Inc. | CKD |
| May 1, 1984 | K841059 | SGPT REAGENT SET Medical Specialties, Inc. | CKD |
| Jul 14, 1982 | K821207 | SGPT REAGENT SET Omega Medical Electronics | CKD |
| Mar 11, 1982 | K820491 | SGPT REAGENT SET Anco Medical Reagents & Assoc. | CKD |
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