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FDA 510(k)

TDX QUINIDINE

K-Number: K822653 · 1982-09-28

ApplicantAbbott Laboratories
Decision Date1982-09-28
Product CodeLBZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TDX QUINIDINE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1982-09-28 under 510(k) number K822653. 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 TDX QUINIDINE?

TDX QUINIDINE is a medical device that received FDA 510(k) clearance on 1982-09-28. The listed applicant is Abbott Laboratories. The 510(k) number is K822653.

When did TDX QUINIDINE receive FDA 510(k) clearance?

TDX QUINIDINE received FDA 510(k) clearance on 1982-09-28, under 510(k) number K822653.

Who is the listed applicant for TDX QUINIDINE?

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

What is the FDA product code for TDX QUINIDINE?

The FDA product code for TDX QUINIDINE is LBZ.

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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.K964212QUINIDINE ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.K955568INNOFLUOR QUINIDINE ASSAY SYSTEMOxis Intl., 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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