Submission Details
| 510(k) Number | K965142 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 23, 1996 |
| Decision Date | March 18, 1997 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)
Mar 1997
Decision
85d
Days
Class 2
Risk
About This 510(k) Submission
K965142 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15), a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on March 18, 1997, 85 days after receiving the submission on December 23, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.
Device Classification
| Product Code | CEC — Radioimmunoassay, Free Thyroxine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1695 |
Manufacturer
Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY · US
ANN M QUINN
33 submissions
33 cleared
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