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FDA 510(k)

OPUS PROCAINAMIDE TEST SYSTEM

K-Number: K934762 · 1994-07-20

ApplicantPb Diagnostic Systems, Inc.
Decision Date1994-07-20
Product CodeLAR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

OPUS PROCAINAMIDE TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pb Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1994-07-20 under 510(k) number K934762. 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 TEST SYSTEM?

OPUS PROCAINAMIDE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1994-07-20. The listed applicant is Pb Diagnostic Systems, Inc.. The 510(k) number is K934762.

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

OPUS PROCAINAMIDE TEST SYSTEM received FDA 510(k) clearance on 1994-07-20, under 510(k) number K934762.

Who is the listed applicant for OPUS PROCAINAMIDE TEST SYSTEM?

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

What is the FDA product code for OPUS PROCAINAMIDE TEST SYSTEM?

The FDA product code for OPUS PROCAINAMIDE TEST SYSTEM is LAR.

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Other records listing Pb Diagnostic Systems, 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.

K940507OPUS FT4 TEST SYSTEMK933389OPUS CMV-GK934137OPUS(R) SEROLOGY CONTROLS, MODIFICATIONK935229OPUS DIGITOXINK934705OPUS NAPAK933066OPUS ESTRADIOL

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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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