K994145 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS. This device is classified as a Calibrator, Primary (Class II - Special Controls, product code JIS).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on December 22, 1999, 14 days after receiving the submission on December 8, 1999.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K994145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 1999 |
| Decision Date | December 22, 1999 |
| Days to Decision | 14 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIS — Calibrator, Primary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |