CKD
11 FDA 510(k) clearances · Product code
52 daysmedian time to decision
108 days90th percentile
11clearances measured
FDA profile
- Official device name
- Hydrazone Colorimetry, Alt/Sgpt
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1030
- Medical specialty
- Clinical Chemistry
- Adverse events (MAUDE)
- 2004: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 (K991834) | Cholestech Corp. | 1999-09-09 |
| ORTHO ALT MICROWELL TEST SYSTEM (K941192) | Ortho Diagnostic Systems, Inc. | 1995-05-16 |
| COBAS READY ALT REAGENT (K896237) | Roche Diagnostic Systems, Inc. | 1990-02-16 |
| VIRGO(R) MICROWELL ALT ASSAY (K884784) | Electro-Nucleonics, Inc. | 1988-12-29 |
| ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) (K883387) | Tech-Co, Inc. | 1988-10-13 |
| REFLOTRON(R) ALT (GPT) (K864082) | Boehringer Mannheim Corp. | 1986-12-04 |
| SGPT (ALT) REAGENT SET (COLORIMETRIC) (K860485) | Sterling Diagnostics, Inc. | 1986-04-03 |
| SGPT REAGENT SET (K844283) | Livonia Diagnostics, Inc. | 1984-11-27 |
| SGPT REAGENT SET (K841059) | Medical Specialties, Inc. | 1984-05-01 |
| SGPT REAGENT SET (K821207) | Omega Medical Electronics | 1982-07-14 |
| SGPT REAGENT SET (K820491) | Anco Medical Reagents & Assoc. | 1982-03-11 |
Track CKD automatically
Every clearance here is in the API, with alerts when new ones post.