Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OralTox Oral Fluid Drug Test

K-Number: K171403 · 2018-02-02

ApplicantPremier Biotech, Inc.
Decision Date2018-02-02
Product CodeDJC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

OralTox Oral Fluid Drug Test is a medical device manufactured by Premier Biotech, Inc.. It received FDA 510(k) clearance on 2018-02-02 under approval number K171403. The device is classified under product code DJC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OralTox Oral Fluid Drug Test?

OralTox Oral Fluid Drug Test is a medical device that received FDA 510(k) clearance on 2018-02-02. It is manufactured by Premier Biotech, Inc.. The 510(k) number is K171403.

When was OralTox Oral Fluid Drug Test approved by the FDA?

OralTox Oral Fluid Drug Test received FDA 510(k) clearance on 2018-02-02, under approval number K171403.

What company makes OralTox Oral Fluid Drug Test?

OralTox Oral Fluid Drug Test is manufactured by Premier Biotech, Inc..

What is the FDA product code for OralTox Oral Fluid Drug Test?

The FDA product code for OralTox Oral Fluid Drug Test is DJC.

Other Devices by Premier Biotech, Inc.

K181305OralTox Oral fluid Drug Test

Related Devices (Code: DJC)

K161044AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)Assure Tech. (Hangzhou) Co, Ltd. K180878BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for RxShanghai Venture Bio-Tech Co., Ltd. K181305OralTox Oral fluid Drug TestPremier Biotech, Inc. K240287LYHER® Oral fluid Multi-Drug Test Kit (Cube)Hangzhou Laihe Biotech Co., Ltd. K253705Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑