K982649 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III. This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on August 12, 1998, 13 days after receiving the submission on July 30, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K982649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 1998 |
| Decision Date | August 12, 1998 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | DIF — Drug Mixture Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |