K012319 is an FDA 510(k) clearance for the RANDOX HUMAN ASSSAYED DRUG CONTROL. This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, GB). The FDA issued a Cleared decision on August 24, 2001, 32 days after receiving the submission on July 23, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K012319 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2001 |
| Decision Date | August 24, 2001 |
| Days to Decision | 32 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 |