CED
9 FDA 510(k) clearances · Product code
30 daysmedian time to decision
102 days90th percentile
9clearances measured
FDA profile
- Official device name
- 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1520
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PHOSPHORUS TEST ITEM NUMBER 65416 (K894288) | Em Diagnostic Systems, Inc. | 1989-08-31 |
| EKTACHEM CLINICAL CHEM. SLIDES (K840151) | Eastman Kodak Company | 1984-03-22 |
| BTC URINE LH ASSAY (K833710) | Btc Diagnostics, Inc. | 1984-01-30 |
| PHOSPHORUS IL (K820832) | American Monitor Corp. | 1982-04-15 |
| SANDARE FAST 340 PHOSPHORUS PROCEDURE (K812670) | Sandare Chemical Co., Inc. | 1981-10-02 |
| SIGMA PROCEDURE 265-UV (K811864) | Sigma Chemical Co. | 1981-07-31 |
| INORGANIC PHOSPHORUS REAGENTS (K811222) | Connecticut Diagnostics, Ltd. | 1981-05-21 |
| CENTRIFICHEM INORGANIC PHOSPHORUS (K802420) | Union Carbide Corp. | 1980-10-31 |
| CENTRIFICHEM INORGANIC PHOSPHORUS (K790662) | Union Carbide Corp. | 1979-05-15 |
Track CED automatically
Every clearance here is in the API, with alerts when new ones post.