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FDA 510(k)

VARELISA RECOMBI ANA SCREEN, MODEL 12 596

K-Number: K083188 · 2009-03-13

ApplicantPhadia US, Inc.
Decision Date2009-03-13
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VARELISA RECOMBI ANA SCREEN, MODEL 12 596 is the device name listed in this FDA 510(k) record. The listed applicant is Phadia US, Inc.. It received FDA 510(k) clearance on 2009-03-13 under 510(k) number K083188. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARELISA RECOMBI ANA SCREEN, MODEL 12 596?

VARELISA RECOMBI ANA SCREEN, MODEL 12 596 is a medical device that received FDA 510(k) clearance on 2009-03-13. The listed applicant is Phadia US, Inc.. The 510(k) number is K083188.

When did VARELISA RECOMBI ANA SCREEN, MODEL 12 596 receive FDA 510(k) clearance?

VARELISA RECOMBI ANA SCREEN, MODEL 12 596 received FDA 510(k) clearance on 2009-03-13, under 510(k) number K083188.

Who is the listed applicant for VARELISA RECOMBI ANA SCREEN, MODEL 12 596?

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

What is the FDA product code for VARELISA RECOMBI ANA SCREEN, MODEL 12 596?

The FDA product code for VARELISA RECOMBI ANA SCREEN, MODEL 12 596 is LJM.

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Other records listing Phadia US, 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.

K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYK122197AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIESK113841IMMUNOCAP ALLERGEN COMPONENTS BUNDLEK112414ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAYK111919IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTSK102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM

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Related Devices (Code: LJM)

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.

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K131185ANA SCREEN ELISA (IGG)Euroimmun USK050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbHK050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbHK041102IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISAImmco Diagnostics, Inc.

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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