The following data is part of a premarket notification filed by Biophor Diagnostics, Inc. with the FDA for Rapidfret Oral Fluid Assay For Amphetamine, Rapidfret Oral Fluid Amphetamine Calibrator Set, Rapidfret Oral Fluid Amphetamine Control Set.
| Device ID | K141748 |
| 510k Number | K141748 |
| Device Name: | RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET |
| Classification | Enzyme Immunoassay, Amphetamine |
| 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 | DKZ |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-30 |
| Decision Date | 2015-05-20 |
| Summary: | summary |