Submission Details
| 510(k) Number | K832823 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 19, 1983 |
| Decision Date | October 14, 1983 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
Cleared
Traditional
K832823 - ENZYMUNE-TEST TSH
(FDA 510(k) Clearance)
Oct 1983
Decision
56d
Days
Class 2
Risk
K832823 is an FDA 510(k) clearance for the ENZYMUNE-TEST TSH, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Icl Scientific (Walker, US). The FDA issued a Cleared decision on October 14, 1983, 56 days after receiving the submission on August 19, 1983. This device falls under the Chemistry 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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