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FDA 510(k)

QUANTA LITE B2GPI IGM

K-Number: K973014 · 1997-10-20

ApplicantInova Diagnostics, Inc.
Decision Date1997-10-20
Product CodeMSV
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE B2GPI IGM is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-10-20 under 510(k) number K973014. 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 QUANTA LITE B2GPI IGM?

QUANTA LITE B2GPI IGM is a medical device that received FDA 510(k) clearance on 1997-10-20. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K973014.

When did QUANTA LITE B2GPI IGM receive FDA 510(k) clearance?

QUANTA LITE B2GPI IGM received FDA 510(k) clearance on 1997-10-20, under 510(k) number K973014.

Who is the listed applicant for QUANTA LITE B2GPI IGM?

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

What is the FDA product code for QUANTA LITE B2GPI IGM?

The FDA product code for QUANTA LITE B2GPI IGM is MSV.

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Other records listing Inova Diagnostics, Inc. as applicant

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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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