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FDA 510(k)

AMPHETAMINES EIA TEST

K-Number: K921554 · 1992-05-04

ApplicantDiagnostic Reagents, Inc.
Decision Date1992-05-04
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMPHETAMINES EIA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1992-05-04 under 510(k) number K921554. 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 AMPHETAMINES EIA TEST?

AMPHETAMINES EIA TEST is a medical device that received FDA 510(k) clearance on 1992-05-04. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K921554.

When did AMPHETAMINES EIA TEST receive FDA 510(k) clearance?

AMPHETAMINES EIA TEST received FDA 510(k) clearance on 1992-05-04, under 510(k) number K921554.

Who is the listed applicant for AMPHETAMINES EIA TEST?

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

What is the FDA product code for AMPHETAMINES EIA TEST?

The FDA product code for AMPHETAMINES EIA TEST is DKZ.

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Other records listing Diagnostic Reagents, Inc. as applicant

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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.

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