Submission Details
| 510(k) Number | K964310 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 29, 1996 |
| Decision Date | November 27, 1996 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)
Nov 1996
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K964310 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010), a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on November 27, 1996, 29 days after receiving the submission on October 29, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1710.
Device Classification
| Product Code | CDP — Radioimmunoassay, Total Triiodothyronine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1710 |
Manufacturer
Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY · US
ANN M QUINN
33 submissions
33 cleared
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