Submission Details
| 510(k) Number | K771222 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 05, 1977 |
| Decision Date | August 04, 1977 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
Cleared
Traditional
K771222 - TSH RIA TEST SYSTEM
(FDA 510(k) Clearance)
Aug 1977
Decision
30d
Days
Class 2
Risk
K771222 is an FDA 510(k) clearance for the TSH RIA TEST SYSTEM. This device is classified as a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW).
Submitted by Monobind (Mchenry, US). The FDA issued a Cleared decision on August 4, 1977, 30 days after receiving the submission on July 5, 1977.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1690.
Device Classification
| Product Code | JLW — Radioimmunoassay, Thyroid-stimulating Hormone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1690 |
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