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FDA 510(k)

ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST

K-Number: K933786 · 1995-03-07

ApplicantImmco Diagnostics, Inc.
Decision Date1995-03-07
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST 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 1995-03-07 under 510(k) number K933786. 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 ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST?

ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST is a medical device that received FDA 510(k) clearance on 1995-03-07. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K933786.

When did ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST receive FDA 510(k) clearance?

ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST received FDA 510(k) clearance on 1995-03-07, under 510(k) number K933786.

Who is the listed applicant for ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST?

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 ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST?

The FDA product code for ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST is MID.

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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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