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 | K181305 |
| 510k Number | K181305 |
| 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 Pritchard DuVal & Associates 825 Nicollet Mall Suite 1820 Minneapolis, MN 55402 |
| Product Code | DJC |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| 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 | 2018-05-17 |
| Decision Date | 2018-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B313OT808071 | K181305 | 000 |
| B313OT807011 | K181305 | 000 |
| B313OT806221 | K181305 | 000 |
| B313OT806051 | K181305 | 000 |
| B313OT805101 | K181305 | 000 |
| B313OT805091 | K181305 | 000 |
| B313OT805081 | K181305 | 000 |
| B313OT804021 | K181305 | 000 |