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FDA 510(k)

VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696

K-Number: K020758 · 2002-05-02

ApplicantPharmacia Deutschland GmbH
Decision Date2002-05-02
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia Deutschland GmbH. It received FDA 510(k) clearance on 2002-05-02 under 510(k) number K020758. 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 IGM ANTIBODIES, MODELS 15648 & 15696?

VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 is a medical device that received FDA 510(k) clearance on 2002-05-02. The listed applicant is Pharmacia Deutschland GmbH. The 510(k) number is K020758.

When did VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 receive FDA 510(k) clearance?

VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 received FDA 510(k) clearance on 2002-05-02, under 510(k) number K020758.

Who is the listed applicant for VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696?

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

What is the FDA product code for VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696?

The FDA product code for VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 is MID.

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Other records listing Pharmacia Deutschland GmbH 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.

K041043VARELISA PR3 ANCA, MODEL NUMBER 17748/17796K040810VARELISA HISTONE ANTIBODIES, MODEL 16496K040811VARELISA SSDNA ANTIBODIES, MODEL 14896K040449VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796K040452VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096K040450VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996

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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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