K050593 is an FDA 510(k) clearance for the ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE. This device is classified as a Enzyme Immunoassay, Barbiturate (Class II - Special Controls, product code DIS).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on May 6, 2005, 59 days after receiving the submission on March 8, 2005.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3150.
| 510(k) Number | K050593 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2005 |
| Decision Date | May 06, 2005 |
| Days to Decision | 59 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 |