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FDA 510(k)

VARELISA RECOMBI CTD SCREEN, MODEL 13096

K-Number: K050967 · 2005-06-28

ApplicantSweden Diagnostics (Germany) GmbH
Decision Date2005-06-28
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VARELISA RECOMBI CTD SCREEN, MODEL 13096 is the device name listed in this FDA 510(k) record. The listed applicant is Sweden Diagnostics (Germany) GmbH. It received FDA 510(k) clearance on 2005-06-28 under 510(k) number K050967. 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 CTD SCREEN, MODEL 13096?

VARELISA RECOMBI CTD SCREEN, MODEL 13096 is a medical device that received FDA 510(k) clearance on 2005-06-28. The listed applicant is Sweden Diagnostics (Germany) GmbH. The 510(k) number is K050967.

When did VARELISA RECOMBI CTD SCREEN, MODEL 13096 receive FDA 510(k) clearance?

VARELISA RECOMBI CTD SCREEN, MODEL 13096 received FDA 510(k) clearance on 2005-06-28, under 510(k) number K050967.

Who is the listed applicant for VARELISA RECOMBI CTD SCREEN, MODEL 13096?

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

What is the FDA product code for VARELISA RECOMBI CTD SCREEN, MODEL 13096?

The FDA product code for VARELISA RECOMBI CTD SCREEN, MODEL 13096 is LJM.

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Other records listing Sweden Diagnostics (Germany) 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.

K050625VARELISA RECOMBI ANA PROFILE, MODEL 18496K042629VARELISA SM ANTIBODIES, MODEL 18296K041173CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996K041357VARELISA GLIADIN IGG ANTIBODIESK041174CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196K041354VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896

View all 8 devices →

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 USK083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.K050625VARELISA 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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