K905457 is an FDA 510(k) clearance for the CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL. This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Consolidated Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on April 16, 1991, 132 days after receiving the submission on December 5, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K905457 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 1990 |
| Decision Date | April 16, 1991 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DIF — Drug Mixture Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |