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FDA 510(k)

QUANTA LITE IGA ACA (HRP)

K-Number: K953366 · 1995-09-01

ApplicantInova Diagnostics, Inc.
Decision Date1995-09-01
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE IGA ACA (HRP) 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 1995-09-01 under 510(k) number K953366. The device is classified under product code MID. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTA LITE IGA ACA (HRP)?

QUANTA LITE IGA ACA (HRP) is a medical device that received FDA 510(k) clearance on 1995-09-01. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K953366.

When did QUANTA LITE IGA ACA (HRP) receive FDA 510(k) clearance?

QUANTA LITE IGA ACA (HRP) received FDA 510(k) clearance on 1995-09-01, under 510(k) number K953366.

Who is the listed applicant for QUANTA LITE IGA ACA (HRP)?

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 IGA ACA (HRP)?

The FDA product code for QUANTA LITE IGA ACA (HRP) is MID.

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Other records listing Inova Diagnostics, Inc. as applicant

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Related Devices (Code: MID)

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.

K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc.K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYPhadia US, Inc.K130528BIOPLEX 2200 APLS IGMBio-Rad LaboratoriesK120817QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGAInova Diagnostics, Inc.K113020IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISASImmco Diagnostics, Inc.K103834BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETSBio-Rad Laboratories

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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