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FDA 510(k)

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA

K-Number: K022945 · 2002-12-18

ApplicantHycor Biomedical, Inc.
Decision Date2002-12-18
Product CodeMSV
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Hycor Biomedical, Inc.. It received FDA 510(k) clearance on 2002-12-18 under 510(k) number K022945. 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 IGG ELISA?

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA is a medical device that received FDA 510(k) clearance on 2002-12-18. The listed applicant is Hycor Biomedical, Inc.. The 510(k) number is K022945.

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

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA received FDA 510(k) clearance on 2002-12-18, under 510(k) number K022945.

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

The FDA 510(k) record lists Hycor Biomedical, Inc. 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 IGG ELISA?

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

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Other records listing Hycor Biomedical, 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.

K081217HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEMK080322HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200K022944AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISAK965094HYCOR ALLERGEN DISCK962728HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODYK962720HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY

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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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