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FDA 510(k)

SCIMEDX PHASE II MPO IGG ANTIBODY EIA

K-Number: K010289 · 2001-03-07

ApplicantScimedx Corp.
Decision Date2001-03-07
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SCIMEDX PHASE II MPO IGG ANTIBODY EIA is the device name listed in this FDA 510(k) record. The listed applicant is Scimedx Corp.. It received FDA 510(k) clearance on 2001-03-07 under 510(k) number K010289. 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 SCIMEDX PHASE II MPO IGG ANTIBODY EIA?

SCIMEDX PHASE II MPO IGG ANTIBODY EIA is a medical device that received FDA 510(k) clearance on 2001-03-07. The listed applicant is Scimedx Corp.. The 510(k) number is K010289.

When did SCIMEDX PHASE II MPO IGG ANTIBODY EIA receive FDA 510(k) clearance?

SCIMEDX PHASE II MPO IGG ANTIBODY EIA received FDA 510(k) clearance on 2001-03-07, under 510(k) number K010289.

Who is the listed applicant for SCIMEDX PHASE II MPO IGG ANTIBODY EIA?

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 SCIMEDX PHASE II MPO IGG ANTIBODY EIA?

The FDA product code for SCIMEDX PHASE II MPO IGG ANTIBODY EIA is MOB.

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Other records listing Scimedx Corp. 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.

K011348PHASE II GBM IGG ANTIBODY EIA TESTK011082TPO IGG ANTIBODY EIA TESTK010625EUROSPITAL EU-TTG IGA UMANAK010287SCIMEDX PHASE II PR3 IGG ANTIBODY EIAK002189GLIADIN IGG ANTIBODY EIA DETECTION SYSTEMK002169GLIADIN 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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