The following data is part of a premarket notification filed by Biophor Diagnostics, Inc. with the FDA for Rapidfret Oral Fluid Assay For Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls.
| Device ID | K142293 |
| 510k Number | K142293 |
| Device Name: | Rapidfret Oral Fluid Assay For Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls |
| Classification | Gas Chromatography, Methamphetamine |
| Applicant | BIOPHOR DIAGNOSTICS, INC. 1201 DOUGLAS AVENUE Redwood City, CA 94063 |
| Contact | Nathaniel G. Butlin |
| Correspondent | Nathaniel G. Butlin BIOPHOR DIAGNOSTICS, INC. 1201 DOUGLAS AVENUE Redwood City, CA 94063 |
| Product Code | LAF |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-18 |
| Decision Date | 2015-09-18 |
| Summary: | summary |