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FDA 510(k)

DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110

K-Number: K032573 · 2003-10-31

ApplicantDade Behring, Inc.
Decision Date2003-10-31
Product CodeLAR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2003-10-31 under 510(k) number K032573. 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 DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110?

DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 is a medical device that received FDA 510(k) clearance on 2003-10-31. The listed applicant is Dade Behring, Inc.. The 510(k) number is K032573.

When did DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 receive FDA 510(k) clearance?

DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 received FDA 510(k) clearance on 2003-10-31, under 510(k) number K032573.

Who is the listed applicant for DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110?

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

What is the FDA product code for DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110?

The FDA product code for DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 is LAR.

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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.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.K962463PROCAINAMIDE ENZYME IMMUNOASSAYDiagnostic Reagents, 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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