The following data is part of a premarket notification filed by Biophor Diagnostics, Inc. with the FDA for Rapidfret Oral Fluid Assay For Cocaine, Rapidfret Oral Fluid Cocaine Calibrator Set, Rapidfret Oral Fluid Cocaine Control Set.
| Device ID | K142129 |
| 510k Number | K142129 |
| Device Name: | RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | BIOPHOR DIAGNOSTICS, INC. 1201 DOUGLAS AVE Redwood City, CA 94063 |
| Contact | Natahaniel G Butlin |
| Correspondent | Natahaniel G Butlin BIOPHOR DIAGNOSTICS, INC. 1201 DOUGLAS AVE Redwood City, CA 94063 |
| Product Code | DIO |
| Subsequent Product Code | DIF |
| Subsequent Product Code | DLJ |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-04 |
| Decision Date | 2015-07-24 |
| Summary: | summary |