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FDA 510(k)

COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR

K-Number: K942847 · 1994-12-02

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1994-12-02
Product CodeLAR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR 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 1994-12-02 under 510(k) number K942847. The device is classified under product code LAR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR?

COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR is a medical device that received FDA 510(k) clearance on 1994-12-02. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K942847.

When did COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR receive FDA 510(k) clearance?

COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR received FDA 510(k) clearance on 1994-12-02, under 510(k) number K942847.

Who is the listed applicant for COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR?

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(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR?

The FDA product code for COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR is LAR.

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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: LAR)

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.

K060773ONLINE TDM PROCAINAMIDERoche Diagnostics Corp.K032573DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110Dade Behring, Inc.K010812EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229Syva Co., Dade Behring, Inc.K971716PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEMBayer Corp.K963306CEDIA N-ACETYLPROCAINAMIDE ASSAYBoehringer Mannheim Corp.K962099CEDIA PROCAINAMIDE ASSAYBoehringer Mannheim Corp.

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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