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FDA 510(k)

DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500

K-Number: K001981 · 2000-08-21

ApplicantAxis-Shield , Ltd.
Decision Date2000-08-21
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield , Ltd.. It received FDA 510(k) clearance on 2000-08-21 under 510(k) number K001981. 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 DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500?

DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 is a medical device that received FDA 510(k) clearance on 2000-08-21. The listed applicant is Axis-Shield , Ltd.. The 510(k) number is K001981.

When did DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 receive FDA 510(k) clearance?

DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 received FDA 510(k) clearance on 2000-08-21, under 510(k) number K001981.

Who is the listed applicant for DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500?

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

What is the FDA product code for DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500?

The FDA product code for DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 is MID.

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Other records listing Axis-Shield , 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.

K042411ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY

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

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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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