K133047 is an FDA 510(k) clearance for the RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU. This device is classified as a Gas Chromatography, Methamphetamine (Class II - Special Controls, product code LAF).
Submitted by Biophor Diagnostics, Inc. (Redwood City, US). The FDA issued a Cleared decision on December 18, 2014, 447 days after receiving the submission on September 27, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3610.
| 510(k) Number | K133047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2013 |
| Decision Date | December 18, 2014 |
| Days to Decision | 447 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LAF — Gas Chromatography, Methamphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3610 |