K970915 is an FDA 510(k) clearance for the DSL ESTRONE-SULFATE RIA. This device is classified as a Radioimmunoassay, Estrone (Class I - General Controls, product code CGF).
Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on May 16, 1997, 65 days after receiving the submission on March 12, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1280.
| 510(k) Number | K970915 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 1997 |
| Decision Date | May 16, 1997 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGF — Radioimmunoassay, Estrone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1280 |