K120504 is an FDA 510(k) clearance for the LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK. 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 March 27, 2012, 35 days after receiving the submission on February 21, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K120504 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 2012 |
| Decision Date | March 27, 2012 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DIF — Drug Mixture Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |