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FDA 510(k)

IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA

K-Number: K030702 · 2003-09-09

ApplicantImmco Diagnostics, Inc.
Decision Date2003-09-09
Product CodeMSV
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 2003-09-09 under 510(k) number K030702. 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 IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA?

IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA is a medical device that received FDA 510(k) clearance on 2003-09-09. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K030702.

When did IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA receive FDA 510(k) clearance?

IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA received FDA 510(k) clearance on 2003-09-09, under 510(k) number K030702.

Who is the listed applicant for IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA?

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

What is the FDA product code for IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA?

The FDA product code for IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA is MSV.

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Other records listing Immco Diagnostics, 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.

K172745ImmuGlo HEp-2 Elite IFAK172078ImmuLisa Enhanced RNA POL III Antibody ELISAK163133ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISAK163177ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISAK162788ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISAK151559ImmuLisa Enhanced Centromere Antibody ELISA

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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.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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