K041696 is an FDA 510(k) clearance for the RAPID READER. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).
Submitted by American Bio Medica Corp. (Beverly, US). The FDA issued a Cleared decision on July 12, 2005, 385 days after receiving the submission on June 22, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K041696 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2004 |
| Decision Date | July 12, 2005 |
| Days to Decision | 385 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 |