K033885 is an FDA 510(k) clearance for the BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT). This device is classified as a Enzyme Immunoassay, Barbiturate (Class II - Special Controls, product code DIS).
Submitted by Lin-Zhi International, Inc. (Synnyvale, US). The FDA issued a Cleared decision on May 19, 2004, 156 days after receiving the submission on December 15, 2003.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3150.
| 510(k) Number | K033885 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2003 |
| Decision Date | May 19, 2004 |
| Days to Decision | 156 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DIS — Enzyme Immunoassay, Barbiturate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3150 |