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FDA 510(k)

VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896

K-Number: K023433 · 2002-11-13

ApplicantPharmacia Diagnostics GmbH & Co. KG
Decision Date2002-11-13
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia Diagnostics GmbH & Co. KG. It received FDA 510(k) clearance on 2002-11-13 under 510(k) number K023433. 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 VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896?

VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 is a medical device that received FDA 510(k) clearance on 2002-11-13. The listed applicant is Pharmacia Diagnostics GmbH & Co. KG. The 510(k) number is K023433.

When did VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 receive FDA 510(k) clearance?

VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 received FDA 510(k) clearance on 2002-11-13, under 510(k) number K023433.

Who is the listed applicant for VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896?

The FDA 510(k) record lists Pharmacia Diagnostics GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896?

The FDA product code for VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 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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