K050682 is an FDA 510(k) clearance for the LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1). This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Bio-Rad Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on April 29, 2005, 44 days after receiving the submission on March 16, 2005.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K050682 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2005 |
| Decision Date | April 29, 2005 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DIF — Drug Mixture Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |