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FDA 510(k)

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA

K-Number: K030397 · 2003-03-21

ApplicantHycor Biomedical , Ltd.
Decision Date2003-03-21
Product CodeMSV
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Hycor Biomedical , Ltd.. It received FDA 510(k) clearance on 2003-03-21 under 510(k) number K030397. 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 AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA?

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA is a medical device that received FDA 510(k) clearance on 2003-03-21. The listed applicant is Hycor Biomedical , Ltd.. The 510(k) number is K030397.

When did AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA receive FDA 510(k) clearance?

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA received FDA 510(k) clearance on 2003-03-21, under 510(k) number K030397.

Who is the listed applicant for AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA?

The FDA 510(k) record lists Hycor Biomedical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA?

The FDA product code for AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA is MSV.

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Other records listing Hycor Biomedical , Ltd. 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.

K043433AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISAK033744AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISAK030741AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA

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.K112414ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAYPhadia US, 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.

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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