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FDA 510(k)

DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600

K-Number: K001574 · 2000-06-09

ApplicantAxis-Shield
Decision Date2000-06-09
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield. It received FDA 510(k) clearance on 2000-06-09 under 510(k) number K001574. 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 IGG/IGM, MODEL FCAR 600?

DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 is a medical device that received FDA 510(k) clearance on 2000-06-09. The listed applicant is Axis-Shield. The 510(k) number is K001574.

When did DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 receive FDA 510(k) clearance?

DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 received FDA 510(k) clearance on 2000-06-09, under 510(k) number K001574.

Who is the listed applicant for DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600?

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

What is the FDA product code for DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600?

The FDA product code for DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 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

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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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