K051088 is an FDA 510(k) clearance for the MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS. This device is classified as a Calibrators, Drug Mixture (Class II - Special Controls, product code DKB).
Submitted by Lin-Zhi International, Inc. (Synnyvale, US). The FDA issued a Cleared decision on June 24, 2005, 57 days after receiving the submission on April 28, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3200.
| 510(k) Number | K051088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2005 |
| Decision Date | June 24, 2005 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DKB — Calibrators, Drug Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3200 |