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FDA 510(k)

OPUS PROCAINAMIDE

K-Number: K951434 · 1995-07-03

ApplicantBehring Diagnostics, Inc.
Decision Date1995-07-03
Product CodeLAR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

OPUS PROCAINAMIDE is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1995-07-03 under 510(k) number K951434. 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 OPUS PROCAINAMIDE?

OPUS PROCAINAMIDE is a medical device that received FDA 510(k) clearance on 1995-07-03. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K951434.

When did OPUS PROCAINAMIDE receive FDA 510(k) clearance?

OPUS PROCAINAMIDE received FDA 510(k) clearance on 1995-07-03, under 510(k) number K951434.

Who is the listed applicant for OPUS PROCAINAMIDE?

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

What is the FDA product code for OPUS PROCAINAMIDE?

The FDA product code for OPUS PROCAINAMIDE is LAR.

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Other records listing Behring Diagnostics, 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.

K973832OPUS HLH CONTROLSK972929N ANTISERUM TO HUMAN ALBUMINK972840N ANTISERUM TO HUMAN TRANSFERRINK973202MODIFICATION OF OPUS FERRITIN TEST SYSTEMK972316OPUS D-DIMERK972116VON WILLEBRAND REAGENT

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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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