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FDA 510(k)

NAPA EIA ASSAY

K-Number: K983812 · 1998-11-16

ApplicantDiagnostic Reagents, Inc.
Decision Date1998-11-16
Product CodeLAN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

NAPA EIA ASSAY 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 1998-11-16 under 510(k) number K983812. 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 NAPA EIA ASSAY?

NAPA EIA ASSAY is a medical device that received FDA 510(k) clearance on 1998-11-16. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K983812.

When did NAPA EIA ASSAY receive FDA 510(k) clearance?

NAPA EIA ASSAY received FDA 510(k) clearance on 1998-11-16, under 510(k) number K983812.

Who is the listed applicant for NAPA EIA ASSAY?

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 NAPA EIA ASSAY?

The FDA product code for NAPA EIA ASSAY is LAN.

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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 ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSK973102LIDOCAINE EIA ASSAYK97283550NG/ML COCAINE METABOLITE CALIBRATOR

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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.

K060738TDM N-ACETYLPROCAINAMIDERoche Diagnostics Corp.K032564DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111Dade Behring, Inc.K011620EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229Syva Co., Dade Behring, 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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