The following data is part of a premarket notification filed by Premier Biotech Inc with the FDA for Oraltox Oral Fluid Drug Test.
| Device ID | K171403 |
| 510k Number | K171403 |
| Device Name: | OralTox Oral Fluid Drug Test |
| Classification | Thin Layer Chromatography, Methamphetamine |
| Applicant | Premier Biotech Inc 723 Kasota Avenue SE Minneapolis, MN 55414 |
| Contact | Jacqueline Gale |
| Correspondent | Lisa L. Pritchard Duval & Associates, P.A. 1820 Medical Arts Building 825 Nicollet Mall Minneapolis, MN 55402 |
| Product Code | DJC |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-12 |
| Decision Date | 2018-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B313OT806021 | K171403 | 000 |
| B313OT805041 | K171403 | 000 |
| B313OT805021 | K171403 | 000 |
| B313OT804041 | K171403 | 000 |
| B313OT804011 | K171403 | 000 |