K822140 is an FDA 510(k) clearance for the IMMUCHEM COVALENT-COAT. This device is classified as a Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) (Class I - General Controls, product code JKC).
Submitted by Immuchem Corp. (Mchenry, US). The FDA issued a Cleared decision on August 5, 1982, 16 days after receiving the submission on July 20, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1245.
| 510(k) Number | K822140 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 1982 |
| Decision Date | August 05, 1982 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JKC — Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1245 |