K770765 is an FDA 510(k) clearance for the REAGENT SET, RENORPACE. This device is classified as a Apparatus, General Use, Thin Layer Chromatography (Class I - General Controls, product code DPA).
Submitted by G.D. Searle and Co. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1977, 58 days after receiving the submission on April 27, 1977.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2270.
| 510(k) Number | K770765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 1977 |
| Decision Date | June 24, 1977 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DPA — Apparatus, General Use, Thin Layer Chromatography |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2270 |