FDA Product Code
FDA Product Code CKD — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1030
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K991834 | CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 | Cholestech Corp. | 1999-09-09 | Traditional | PDF ↗ |
| K941192 | ORTHO ALT MICROWELL TEST SYSTEM | Ortho Diagnostic Systems, Inc. | 1995-05-16 | Traditional | PDF ↗ |
| K896237 | COBAS READY ALT REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K884784 | VIRGO(R) MICROWELL ALT ASSAY | Electro-Nucleonics, Inc. | 1988-12-29 | Traditional | PDF ↗ |
| K883387 | ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) | Tech-Co, Inc. | 1988-10-13 | Traditional | PDF ↗ |
| K864082 | REFLOTRON(R) ALT (GPT) | Boehringer Mannheim Corp. | 1986-12-04 | Traditional | PDF ↗ |
| K860485 | SGPT (ALT) REAGENT SET (COLORIMETRIC) | Sterling Diagnostics, Inc. | 1986-04-03 | Traditional | PDF ↗ |
| K844283 | SGPT REAGENT SET | Livonia Diagnostics, Inc. | 1984-11-27 | Traditional | PDF ↗ |
| K841059 | SGPT REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K821207 | SGPT REAGENT SET | Omega Medical Electronics | 1982-07-14 | Traditional | PDF ↗ |
| K820491 | SGPT REAGENT SET | Anco Medical Reagents & Assoc. | 1982-03-11 | Traditional | PDF ↗ |
Product code CKD · Class I · Clinical Chemistry. Data: openFDA.