K970016 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020). This device is classified as 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 January 30, 1997, 28 days after receiving the submission on January 2, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1710.
| 510(k) Number | K970016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 1997 |
| Decision Date | January 30, 1997 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CDP — Radioimmunoassay, Total Triiodothyronine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1710 |