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FDA 510(k)

ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM

K-Number: K911661 · 1991-12-09

ApplicantImmuno Concepts, Inc.
Decision Date1991-12-09
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Concepts, Inc.. It received FDA 510(k) clearance on 1991-12-09 under 510(k) number K911661. 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 TEST SYSTEM?

ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1991-12-09. The listed applicant is Immuno Concepts, Inc.. The 510(k) number is K911661.

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

ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM received FDA 510(k) clearance on 1991-12-09, under 510(k) number K911661.

Who is the listed applicant for ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM?

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

What is the FDA product code for ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM?

The FDA product code for ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM is MID.

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Other records listing Immuno Concepts, 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.

K013432IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040GK013283RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16K013285RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15K992041RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11K983924HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-ROK972145HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM

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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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