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FDA 510(k)

AXSYM N-ACETYLPROCAINAMIDE

K-Number: K955422 · 1996-04-24

ApplicantAbbott Laboratories
Decision Date1996-04-24
Product CodeLAN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AXSYM N-ACETYLPROCAINAMIDE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1996-04-24 under 510(k) number K955422. The device is classified under product code LAN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXSYM N-ACETYLPROCAINAMIDE?

AXSYM N-ACETYLPROCAINAMIDE is a medical device that received FDA 510(k) clearance on 1996-04-24. The listed applicant is Abbott Laboratories. The 510(k) number is K955422.

When did AXSYM N-ACETYLPROCAINAMIDE receive FDA 510(k) clearance?

AXSYM N-ACETYLPROCAINAMIDE received FDA 510(k) clearance on 1996-04-24, under 510(k) number K955422.

Who is the listed applicant for AXSYM N-ACETYLPROCAINAMIDE?

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 AXSYM N-ACETYLPROCAINAMIDE?

The FDA product code for AXSYM N-ACETYLPROCAINAMIDE is LAN.

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Related Devices (Code: LAN)

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.

K060738TDM N-ACETYLPROCAINAMIDERoche Diagnostics Corp.K032564DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111Dade Behring, Inc.K011620EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229Syva Co., Dade Behring, Inc.K983812NAPA EIA ASSAYDiagnostic Reagents, Inc.K971713N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEMBayer Corp.K934705OPUS NAPAPb 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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