K791664 is an FDA 510(k) clearance for the IMMUCHEM COVALENT COAT SOLID PHASE ASSAY. This device is classified as a Radioimmunoassay, Total Thyroxine (Class II - Special Controls, product code CDX).
Submitted by Immuchem Corp. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1979, 37 days after receiving the submission on August 21, 1979.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1700.
| 510(k) Number | K791664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 1979 |
| Decision Date | September 27, 1979 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDX — Radioimmunoassay, Total Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1700 |