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FDA 510(k)

QUINIDINE ENZYME IMMUNOASSAY

K-Number: K964212 · 1996-12-18

ApplicantDiagnostic Reagents, Inc.
Decision Date1996-12-18
Product CodeLBZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUINIDINE 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 1996-12-18 under 510(k) number K964212. The device is classified under product code LBZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUINIDINE ENZYME IMMUNOASSAY?

QUINIDINE ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1996-12-18. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K964212.

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

QUINIDINE ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1996-12-18, under 510(k) number K964212.

Who is the listed applicant for QUINIDINE 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 QUINIDINE ENZYME IMMUNOASSAY?

The FDA product code for QUINIDINE ENZYME IMMUNOASSAY is LBZ.

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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: LBZ)

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.

K052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORSSeradyn, Inc.K032332ROCHE ONLINE TDM QUINIDINERoche Diagnostics Corp.K011605EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229Syva Co., Dade Behring, Inc.K964116QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.K955568INNOFLUOR QUINIDINE ASSAY SYSTEMOxis Intl., Inc.K941440COBAS-FP QUINIDINE REAGENTS AND CALIBRATORSRoche Diagnostic Systems, Inc.

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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