CIO
11 FDA 510(k) clearances · Product code
31 daysmedian time to decision
77 days90th percentile
11clearances measured
FDA profile
- Official device name
- Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT (K880177) | Tech-Co, Inc. | 1988-04-05 |
| ALKALINE PHOSPHATASE REAGENT SET (K860351) | Sterling Diagnostics, Inc. | 1986-02-11 |
| ALKALINE PHOSPHATASE REAGENT SET (K855192) | Technostics Intl. | 1986-01-14 |
| SANDARE ALKALINE PHOSPHATASE PROCEDURE (K844498) | Sandare Chemical Co., Inc. | 1984-12-10 |
| ALKALINE PHOSPHATASE REAGENT SET (K844237) | Livonia Diagnostics, Inc. | 1984-11-20 |
| ALKALINE PHOSPHOTASE REAGENT SET (K841064) | Medical Specialties, Inc. | 1984-05-01 |
| COBAS STANDARDS FOR CALCIUM-IN-ORGANIC (K823578) | Hoffmann-La Roche, Inc. | 1983-01-07 |
| ALKALINE PHOSPHOTASE REAGENT SET (K821200) | Omega Medical Electronics | 1982-07-13 |
| ALP TEST (K781324) | Analytical & Research Chemicals, Inc. | 1978-08-31 |
| ALKALINE PHOSPHATASE TEST SET (K772257) | Stanbio Laboratory | 1977-12-22 |
| PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE (K770453) | Icn Pharmaceuticals, Inc. | 1977-05-03 |
Track CIO automatically
Every clearance here is in the API, with alerts when new ones post.