K942369 is an FDA 510(k) clearance for the GAMMA-BCT INTACT PTH. This device is classified as a Radioimmunoassay, Parathyroid Hormone (Class II - Special Controls, product code CEW).
Submitted by Immunodiagnostic Systems , Ltd. (Tyne And Wear, GB). The FDA issued a Cleared decision on September 20, 1994, 125 days after receiving the submission on May 18, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1545.
| 510(k) Number | K942369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 1994 |
| Decision Date | September 20, 1994 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CEW — Radioimmunoassay, Parathyroid Hormone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1545 |