FDA Product Code
FDA Product Code CKE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1020
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K914167 | CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE | Eastman Kodak Company | 1992-03-17 | Traditional | PDF ↗ |
| K915705 | ACID PHOSPHATASE REAGENT SET | Tech Intl. Co. | 1992-02-27 | Traditional | PDF ↗ |
| K873726 | ACID PHOSPHATASE TEST | King Diagnostics, Inc. | 1988-01-27 | Traditional | PDF ↗ |
| K864230 | DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM | E.I. Dupont DE Nemours & Co., Inc. | 1986-11-28 | Traditional | PDF ↗ |
| K860476 | ACID PHOSPHATASE REAGENT SET | Sterling Diagnostics, Inc. | 1986-03-05 | Traditional | PDF ↗ |
| K843380 | ACID PHOSPHATASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-09-20 | Traditional | PDF ↗ |
| K821526 | ACID PHOSPHATASE REAGENT SET | Anco Medical Reagents & Assoc. | 1982-06-10 | Traditional | PDF ↗ |
| K800693 | STANBIO PROSTATIC ACID PHOSPHATASE TEST | Stanbio Laboratory | 1980-04-16 | Traditional | PDF ↗ |
| K790524 | DATA-ZYME ACIA PHOSPHATASE PROCEDURE | Data Medical Associates, Inc. | 1979-05-23 | Traditional | PDF ↗ |
Product code CKE · Class II · Clinical Chemistry. Data: openFDA.