510(k) K181305
K181305 is an FDA 510(k) premarket notification submitted by Premier Biotech, Inc. for the device "OralTox Oral fluid Drug Test". The FDA issued a decision of Substantially Equivalent on September 20, 2018. The device falls under product code DJC (Thin Layer Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. Premier Biotech, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 2018
- Date Received
- May 17, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Thin Layer Chromatography, Methamphetamine
- Device Class
- Class II
- Regulation Number
- 862.3610
- Review Panel
- TX
- Submission Type