Submission Details
| 510(k) Number | K964721 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 25, 1996 |
| Decision Date | December 18, 1996 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)
Dec 1996
Decision
23d
Days
Class 2
Risk
About This 510(k) Submission
K964721 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005), a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II — Special Controls, product code KLI), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on December 18, 1996, 23 days after receiving the submission on November 25, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.
Device Classification
| Product Code | KLI — Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1700 |
Manufacturer
Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY · US
ANN M QUINN
33 submissions
33 cleared
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