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FDA 510(k)

COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS

K-Number: K941440 · 1994-07-06

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1994-07-06
Product CodeLBZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1994-07-06 under 510(k) number K941440. 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 COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS?

COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS is a medical device that received FDA 510(k) clearance on 1994-07-06. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K941440.

When did COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS receive FDA 510(k) clearance?

COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS received FDA 510(k) clearance on 1994-07-06, under 510(k) number K941440.

Who is the listed applicant for COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS?

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

What is the FDA product code for COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS?

The FDA product code for COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS is LBZ.

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Other records listing Roche Diagnostic Systems, 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.

K983698MODIFICATION TO ABUSCREEN ONLINE BARBITURATESK983702MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINESK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINEK983556ABUSCREEN ONLINE BENZ 300 CALIBRATORSK983555ABUSCREEN ONLINE BENZ 200 CALIBRATORSK983700MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE

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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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