Submission Details
| 510(k) Number | K964558 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 13, 1996 |
| Decision Date | December 16, 1996 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)
Dec 1996
Decision
33d
Days
Class 2
Risk
About This 510(k) Submission
K964558 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001), a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on December 16, 1996, 33 days after receiving the submission on November 13, 1996. 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 |
Manufacturer
Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY · US
ANN M QUINN
33 submissions
33 cleared
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