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FDA 510(k)

QAB2A IGM ELISA KIT HRP

K-Number: K021610 · 2002-07-12

ApplicantCheshire Diagnostics , Ltd.
Decision Date2002-07-12
Product CodeMSV
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QAB2A IGM ELISA KIT HRP is the device name listed in this FDA 510(k) record. The listed applicant is Cheshire Diagnostics , Ltd.. It received FDA 510(k) clearance on 2002-07-12 under 510(k) number K021610. 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 QAB2A IGM ELISA KIT HRP?

QAB2A IGM ELISA KIT HRP is a medical device that received FDA 510(k) clearance on 2002-07-12. The listed applicant is Cheshire Diagnostics , Ltd.. The 510(k) number is K021610.

When did QAB2A IGM ELISA KIT HRP receive FDA 510(k) clearance?

QAB2A IGM ELISA KIT HRP received FDA 510(k) clearance on 2002-07-12, under 510(k) number K021610.

Who is the listed applicant for QAB2A IGM ELISA KIT HRP?

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

What is the FDA product code for QAB2A IGM ELISA KIT HRP?

The FDA product code for QAB2A IGM ELISA KIT HRP is MSV.

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Other records listing Cheshire Diagnostics , 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.

K021611QAB2A IGG ELISA KIT HRPK021192QACA IGG/IGM ELISA KIT HRPK020694QAB2A IGM ELISA KITK020695QAB2A IGG ELISA KITK020241QACA IGG/IGM ELISA KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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