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FDA 510(k)

BENZODIAZEPINE ENZYME IMMUNOASSAY

K-Number: K930529 · 1993-08-05

ApplicantDiagnostic Reagents, Inc.
Decision Date1993-08-05
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BENZODIAZEPINE ENZYME IMMUNOASSAY 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 1993-08-05 under 510(k) number K930529. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BENZODIAZEPINE ENZYME IMMUNOASSAY?

BENZODIAZEPINE ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1993-08-05. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K930529.

When did BENZODIAZEPINE ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

BENZODIAZEPINE ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1993-08-05, under 510(k) number K930529.

Who is the listed applicant for BENZODIAZEPINE ENZYME IMMUNOASSAY?

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 BENZODIAZEPINE ENZYME IMMUNOASSAY?

The FDA product code for BENZODIAZEPINE ENZYME IMMUNOASSAY is JXM.

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Other records listing Diagnostic Reagents, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYK983812NAPA EIA ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSK973102LIDOCAINE EIA ASSAY

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Related Devices (Code: JXM)

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K243498Alinity c Benzodiazepines Reagent KitMicrogenics CorporationK221765ONLINE DAT Benzodiazepines IIRoche DiagnosticsK190968CEDIA Benzodiazepine AssayMicrogenics CorporationK173963DRI Benzodiazepine AssayMicrogenics CorporationK163590Psychemedics Microplate EIA for Benzodiazepines in HairPsychemedics CorporationK163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen 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.

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