K063024 is an FDA 510(k) clearance for the LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).
Submitted by Lin-Zhi International, Inc. (Synnyvale, US). The FDA issued a Cleared decision on October 30, 2006, 28 days after receiving the submission on October 2, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K063024 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2006 |
| Decision Date | October 30, 2006 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DKZ — Enzyme Immunoassay, Amphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3100 |