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FDA 510(k)

EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES

K-Number: K954105 · 1996-03-19

ApplicantScimedx Corp.
Decision Date1996-03-19
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES is the device name listed in this FDA 510(k) record. The listed applicant is Scimedx Corp.. It received FDA 510(k) clearance on 1996-03-19 under 510(k) number K954105. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES?

EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES is a medical device that received FDA 510(k) clearance on 1996-03-19. The listed applicant is Scimedx Corp.. The 510(k) number is K954105.

When did EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES receive FDA 510(k) clearance?

EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES received FDA 510(k) clearance on 1996-03-19, under 510(k) number K954105.

Who is the listed applicant for EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES?

The FDA 510(k) record lists Scimedx Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES?

The FDA product code for EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES is MOB.

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Other records listing Scimedx Corp. as applicant

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K011348PHASE II GBM IGG ANTIBODY EIA TESTK011082TPO IGG ANTIBODY EIA TESTK010625EUROSPITAL EU-TTG IGA UMANAK010287SCIMEDX PHASE II PR3 IGG ANTIBODY EIAK010289SCIMEDX PHASE II MPO IGG ANTIBODY EIAK002169GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM

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Related Devices (Code: MOB)

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.

K261466Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMZeus ScientificK243776Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)Zeus ScientificK172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternEuroimmun Us, Inc.K172461AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinAesku.Diagnostics GmbH & Co. KGK173792EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayPhadia ABK161258NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitInova Diagnostics, 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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