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FDA 510(k)

GENPRIME DRUGS OF ABUSE READER SYSTEM

K-Number: K130082 · 2013-12-20

ApplicantGenprime, Inc.
Decision Date2013-12-20
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

GENPRIME DRUGS OF ABUSE READER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Genprime, Inc.. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K130082. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENPRIME DRUGS OF ABUSE READER SYSTEM?

GENPRIME DRUGS OF ABUSE READER SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Genprime, Inc.. The 510(k) number is K130082.

When did GENPRIME DRUGS OF ABUSE READER SYSTEM receive FDA 510(k) clearance?

GENPRIME DRUGS OF ABUSE READER SYSTEM received FDA 510(k) clearance on 2013-12-20, under 510(k) number K130082.

Who is the listed applicant for GENPRIME DRUGS OF ABUSE READER SYSTEM?

The FDA 510(k) record lists Genprime, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENPRIME DRUGS OF ABUSE READER SYSTEM?

The FDA product code for GENPRIME DRUGS OF ABUSE READER SYSTEM is DKZ.

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Related Devices (Code: DKZ)

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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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