K935013 is an FDA 510(k) clearance for the DSL ESTRONE (DSL 8700). 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 June 16, 1994, 239 days after receiving the submission on October 20, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1280.
| 510(k) Number | K935013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1993 |
| Decision Date | June 16, 1994 |
| Days to Decision | 239 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CGF — Radioimmunoassay, Estrone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1280 |