K831855 is an FDA 510(k) clearance for the HATCH KIT. This device is classified as a Radioimmunoassay, Acth (Class II - Special Controls, product code CKG).
Submitted by Radioassay Systems Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1983, 49 days after receiving the submission on June 9, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1025.
| 510(k) Number | K831855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 1983 |
| Decision Date | July 28, 1983 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CKG — Radioimmunoassay, Acth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1025 |