K050988 is an FDA 510(k) clearance for the OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS. This device is classified as a Coating, Liquid, Glc (Class I - General Controls, product code DLG).
Submitted by Lin-Zhi International, Inc. (Synnyvale, US). The FDA issued a Cleared decision on April 6, 2006, 352 days after receiving the submission on April 19, 2005.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2250.
| 510(k) Number | K050988 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2005 |
| Decision Date | April 06, 2006 |
| Days to Decision | 352 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DLG — Coating, Liquid, Glc |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2250 |