K791497 is an FDA 510(k) clearance for the PROSTATIC ACID RADIOIMMUNOASSAY TEST. This device is classified as a Acid Phosphatase (prostatic), Tartrate Inhibited (Class II - Special Controls, product code JFH).
Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1979, 123 days after receiving the submission on August 3, 1979.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1020.
| 510(k) Number | K791497 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 1979 |
| Decision Date | December 04, 1979 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JFH — Acid Phosphatase (prostatic), Tartrate Inhibited |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1020 |