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FDA 510(k)

TDM N-ACETYLPROCAINAMIDE

K-Number: K060738 · 2006-08-16

ApplicantRoche Diagnostics Corp.
Decision Date2006-08-16
Product CodeLAN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TDM N-ACETYLPROCAINAMIDE is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2006-08-16 under 510(k) number K060738. 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 TDM N-ACETYLPROCAINAMIDE?

TDM N-ACETYLPROCAINAMIDE is a medical device that received FDA 510(k) clearance on 2006-08-16. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K060738.

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

TDM N-ACETYLPROCAINAMIDE received FDA 510(k) clearance on 2006-08-16, under 510(k) number K060738.

Who is the listed applicant for TDM N-ACETYLPROCAINAMIDE?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TDM N-ACETYLPROCAINAMIDE?

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

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Other records listing Roche Diagnostics Corp. 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.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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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.

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.K955422AXSYM N-ACETYLPROCAINAMIDEAbbott LaboratoriesK934705OPUS 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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