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FDA 510(k)

INNOFLUOR QUINIDINE ASSAY SYSTEM

K-Number: K955568 · 1996-04-04

ApplicantOxis Intl., Inc.
Decision Date1996-04-04
Product CodeLBZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INNOFLUOR QUINIDINE ASSAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Oxis Intl., Inc.. It received FDA 510(k) clearance on 1996-04-04 under 510(k) number K955568. 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 INNOFLUOR QUINIDINE ASSAY SYSTEM?

INNOFLUOR QUINIDINE ASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1996-04-04. The listed applicant is Oxis Intl., Inc.. The 510(k) number is K955568.

When did INNOFLUOR QUINIDINE ASSAY SYSTEM receive FDA 510(k) clearance?

INNOFLUOR QUINIDINE ASSAY SYSTEM received FDA 510(k) clearance on 1996-04-04, under 510(k) number K955568.

Who is the listed applicant for INNOFLUOR QUINIDINE ASSAY SYSTEM?

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

What is the FDA product code for INNOFLUOR QUINIDINE ASSAY SYSTEM?

The FDA product code for INNOFLUOR QUINIDINE ASSAY SYSTEM is LBZ.

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Other records listing Oxis Intl., 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.

K972331INNOFLUOR GENTAMICIN ASSAY SYSTEMK972330INNOFLUOR PHENOBARBITAL ASSAY SYSTEMK970510INNOFLOUR TOPIRAMATE REAGENT SETK970509INNOFLOUR CALIBRATOR REAGENT SETK970517INNOFLUOR TOPIRAMATE CONTROL SETK955569INNOFLUOR GENTAMICIN ASSAY SYSTEM

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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.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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