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FDA 510(k)

PROCAINAMIDE ENZYME IMMUNOASSAY

K-Number: K962463 · 1996-08-14

ApplicantDiagnostic Reagents, Inc.
Decision Date1996-08-14
Product CodeLAR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PROCAINAMIDE ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1996-08-14 under 510(k) number K962463. 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 PROCAINAMIDE ENZYME IMMUNOASSAY?

PROCAINAMIDE ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1996-08-14. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K962463.

When did PROCAINAMIDE ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

PROCAINAMIDE ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1996-08-14, under 510(k) number K962463.

Who is the listed applicant for PROCAINAMIDE ENZYME IMMUNOASSAY?

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

What is the FDA product code for PROCAINAMIDE ENZYME IMMUNOASSAY?

The FDA product code for PROCAINAMIDE ENZYME IMMUNOASSAY is LAR.

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Other records listing Diagnostic Reagents, 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.

K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYK983812NAPA EIA ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSK973102LIDOCAINE EIA ASSAY

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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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