CKE
9 FDA 510(k) clearances · Product code
31 daysmedian time to decision
182 days90th percentile
9clearances measured
FDA profile
- Official device name
- Acid Phosphatase, Thymolphthale Inmonophosphate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1020
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE (K914167) | Eastman Kodak Company | 1992-03-17 |
| ACID PHOSPHATASE REAGENT SET (K915705) | Tech Intl. Co. | 1992-02-27 |
| ACID PHOSPHATASE TEST (K873726) | King Diagnostics, Inc. | 1988-01-27 |
| DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM (K864230) | E.I. Dupont DE Nemours & Co., Inc. | 1986-11-28 |
| ACID PHOSPHATASE REAGENT SET (K860476) | Sterling Diagnostics, Inc. | 1986-03-05 |
| ACID PHOSPHATASE ASSAY KIT (K843380) | Diagnostic Chemicals, Ltd. (Usa) | 1984-09-20 |
| ACID PHOSPHATASE REAGENT SET (K821526) | Anco Medical Reagents & Assoc. | 1982-06-10 |
| STANBIO PROSTATIC ACID PHOSPHATASE TEST (K800693) | Stanbio Laboratory | 1980-04-16 |
| DATA-ZYME ACIA PHOSPHATASE PROCEDURE (K790524) | Data Medical Associates, Inc. | 1979-05-23 |
Track CKE automatically
Every clearance here is in the API, with alerts when new ones post.