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FDA 510(k)

OralTox Oral fluid Drug Test

K-Number: K181305 · 2018-09-20

ApplicantPremier Biotech, Inc.
Decision Date2018-09-20
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 2018-09-20 under approval number K181305. 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 2018-09-20. It is manufactured by Premier Biotech, Inc.. The 510(k) number is K181305.

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

OralTox Oral fluid Drug Test received FDA 510(k) clearance on 2018-09-20, under approval number K181305.

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.

K171403OralTox Oral Fluid Drug Test

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Official Source

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

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