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FDA 510(k)

ONLINE TDM PROCAINAMIDE

K-Number: K060773 · 2006-08-23

ApplicantRoche Diagnostics Corp.
Decision Date2006-08-23
Product CodeLAR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONLINE TDM PROCAINAMIDE 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 2006-08-23 under 510(k) number K060773. 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 ONLINE TDM PROCAINAMIDE?

ONLINE TDM PROCAINAMIDE is a medical device that received FDA 510(k) clearance on 2006-08-23. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K060773.

When did ONLINE TDM PROCAINAMIDE receive FDA 510(k) clearance?

ONLINE TDM PROCAINAMIDE received FDA 510(k) clearance on 2006-08-23, under 510(k) number K060773.

Who is the listed applicant for ONLINE TDM PROCAINAMIDE?

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 ONLINE TDM PROCAINAMIDE?

The FDA product code for ONLINE TDM PROCAINAMIDE is LAR.

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Other records listing Roche Diagnostics Corp. as applicant

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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.

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.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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