K191099 is an FDA 510(k) clearance for the Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).
Submitted by Atlas Medical (Amman, JO). The FDA issued a Cleared decision on October 3, 2019, 161 days after receiving the submission on April 25, 2019.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K191099 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2019 |
| Decision Date | October 03, 2019 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DKZ - Enzyme Immunoassay, Amphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3100 |