FDA Product Code
FDA Product Code CIO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1050
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K880177 | ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT | Tech-Co, Inc. | 1988-04-05 | Traditional | PDF ↗ |
| K860351 | ALKALINE PHOSPHATASE REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-11 | Traditional | PDF ↗ |
| K855192 | ALKALINE PHOSPHATASE REAGENT SET | Technostics Intl. | 1986-01-14 | Traditional | PDF ↗ |
| K844498 | SANDARE ALKALINE PHOSPHATASE PROCEDURE | Sandare Chemical Co., Inc. | 1984-12-10 | Traditional | PDF ↗ |
| K844237 | ALKALINE PHOSPHATASE REAGENT SET | Livonia Diagnostics, Inc. | 1984-11-20 | Traditional | PDF ↗ |
| K841064 | ALKALINE PHOSPHOTASE REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K823578 | COBAS STANDARDS FOR CALCIUM-IN-ORGANIC | Hoffmann-La Roche, Inc. | 1983-01-07 | Traditional | PDF ↗ |
| K821200 | ALKALINE PHOSPHOTASE REAGENT SET | Omega Medical Electronics | 1982-07-13 | Traditional | PDF ↗ |
| K781324 | ALP TEST | Analytical & Research Chemicals, Inc. | 1978-08-31 | Traditional | PDF ↗ |
| K772257 | ALKALINE PHOSPHATASE TEST SET | Stanbio Laboratory | 1977-12-22 | Traditional | PDF ↗ |
| K770453 | PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE | Icn Pharmaceuticals, Inc. | 1977-05-03 | Traditional | PDF ↗ |
Product code CIO · Class II · Clinical Chemistry. Data: openFDA.