The following data is part of a premarket notification filed by Biophor Diagnostics, Inc. with the FDA for Rapidfret Oral Fluid Assay For Pcp, Pcp Calibrator Set, Pcp Control Set And Rapidease Oral Fluid Collector.
| Device ID | K122703 |
| 510k Number | K122703 |
| Device Name: | RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR |
| Classification | Enzyme Immunoassay, Phencyclidine |
| 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 | LCM |
| Subsequent Product Code | DIF |
| Subsequent Product Code | DKB |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-04 |
| Decision Date | 2013-04-25 |
| Summary: | summary |