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FDA 510(k)

ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY

K-Number: K112414 · 2012-06-22

ApplicantPhadia US, Inc.
Decision Date2012-06-22
Product CodeMSV
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Phadia US, Inc.. It received FDA 510(k) clearance on 2012-06-22 under 510(k) number K112414. The device is classified under product code MSV. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY?

ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2012-06-22. The listed applicant is Phadia US, Inc.. The 510(k) number is K112414.

When did ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY receive FDA 510(k) clearance?

ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY received FDA 510(k) clearance on 2012-06-22, under 510(k) number K112414.

Who is the listed applicant for ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY?

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

What is the FDA product code for ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY?

The FDA product code for ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY is MSV.

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Other records listing Phadia US, 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.

K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYK122197AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIESK113841IMMUNOCAP ALLERGEN COMPONENTS BUNDLEK111919IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTSK102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMK093459ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01

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Related Devices (Code: MSV)

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.

K243979Aptiva APS IgA ReagentInova Diagnostics, Inc.K181329EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayPhadia ABK162788ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.K091556HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLSInstrumentation Laboratory COK092757THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCRThera-Test Laboratories, Inc.K072032IGG ANTI-ATHEROX TEST KITCorgenix, 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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