OralTox Oral fluid Drug Test
FDA 510(k) K181305 · Premier Biotech, Inc.
510(k) numberK181305
Submission
- Device name
- OralTox Oral fluid Drug Test
- Applicant
- Premier Biotech, Inc.
Minneapolis, MN, US - Received
- May 17, 2018
- Decision date
- September 20, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJC – Thin Layer Chromatography, Methamphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3610
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJC
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|---|---|---|---|
| K253705 | Healgen® Accurate Oral Fluid Drug TestDJC · Traditional | Healgen Scientific,, LLC | 03/16/2026SE |
| K240287 | LYHER® Oral fluid Multi-Drug Test Kit (Cube)DJC · Traditional | Hangzhou Laihe Biotech Co., Ltd. | 03/18/2025SE |
| K180878 | BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test…DJC · Traditional | Shanghai Venture Bio-Tech Co., Ltd. | 12/17/2018SE |
| K171403 | OralTox Oral Fluid Drug TestDJC · Traditional | Premier Biotech, Inc. | 02/02/2018SE |
| K161044 | AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…DJC · Traditional | Assure Tech. (Hangzhou) Co, Ltd. | 07/06/2016SE |
| K132630 | Wondfo Oxazepam Urine Test (Bzo 200) and Wondfo Methamphetamine Urine Test (Met 300)DJC · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 09/27/2013SE |
| K080347 | Uniscan -Doa SystemDJC · Traditional | Taiwan Unison Biotech, Inc. | 10/09/2008SE |
| K060355 | Acro Biotech LLC Rapid Mdma Urine Test, Catalog MDMA0010000DJC · Traditional | Acro Biotech, LLC | 08/07/2006SE |
| K060896 | Modification to Ontrak Testcup II and Onsite CupkitDJC · Traditional | Varian, Inc. | 06/09/2006SE |
| K053033 | Acro Biotech LLC Rapid Methamphetamine Urine Test; Catalog# MET001000DJC · Traditional | Acro Biotech, LLC | 06/06/2006SE |
More from Acro Biotech, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K171403 | OralTox Oral Fluid Drug TestDJC · Traditional | 02/02/2018SE |
Questions and answers
When was OralTox Oral fluid Drug Test cleared by the FDA?
OralTox Oral fluid Drug Test (K181305) received a 510(k) decision of Substantially Equivalent on September 20, 2018, 126 days after the submission was received.
What is the product code of K181305?
The FDA product code is DJC – Thin Layer Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.