The following data is part of a premarket notification filed by Biophor Diagnostics, Inc. with the FDA for Rapidfret Oral Fluid Assay For Opiates; Rapidfret Oral Fluid Calibrators, Controls, Collector; Rapidfret Integrated Work.
| Device ID | K133642 |
| 510k Number | K133642 |
| Device Name: | RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | BIOPHOR DIAGNOSTICS, INC. 1201 DOUGLAS AVE Redwood City, CA 94063 |
| Contact | Nathaniel G Butlin |
| Correspondent | Nathaniel G Butlin BIOPHOR DIAGNOSTICS, INC. 1201 DOUGLAS AVE Redwood City, CA 94063 |
| Product Code | DJG |
| Subsequent Product Code | DIF |
| Subsequent Product Code | DKB |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-27 |
| Decision Date | 2014-01-24 |
| Summary: | summary |