K781150 is an FDA 510(k) clearance for the RIA TSH IN HUMAN SERUM OR PLASMA. This device is classified as a Radioimmunoassay, Thyroid-stimulating Hormone (Class II - Special Controls, product code JLW).
Submitted by Diagnostic Corp. of America (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978, 17 days after receiving the submission on July 10, 1978.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1690.
| 510(k) Number | K781150 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 1978 |
| Decision Date | July 27, 1978 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JLW — Radioimmunoassay, Thyroid-stimulating Hormone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1690 |