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FDA 510(k)

VARELISA MPO ANCA, MODEL 17648/17696

K-Number: K041040 · 2004-06-16

ApplicantSweden Diagnostics (Germany) GmbH
Decision Date2004-06-16
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VARELISA MPO ANCA, MODEL 17648/17696 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 2004-06-16 under 510(k) number K041040. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARELISA MPO ANCA, MODEL 17648/17696?

VARELISA MPO ANCA, MODEL 17648/17696 is a medical device that received FDA 510(k) clearance on 2004-06-16. The listed applicant is Sweden Diagnostics (Germany) GmbH. The 510(k) number is K041040.

When did VARELISA MPO ANCA, MODEL 17648/17696 receive FDA 510(k) clearance?

VARELISA MPO ANCA, MODEL 17648/17696 received FDA 510(k) clearance on 2004-06-16, under 510(k) number K041040.

Who is the listed applicant for VARELISA MPO ANCA, MODEL 17648/17696?

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 MPO ANCA, MODEL 17648/17696?

The FDA product code for VARELISA MPO ANCA, MODEL 17648/17696 is MOB.

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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.

K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096K050625VARELISA RECOMBI ANA PROFILE, MODEL 18496K042629VARELISA SM ANTIBODIES, MODEL 18296K041173CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996K041357VARELISA GLIADIN IGG ANTIBODIESK041174CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196

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Related Devices (Code: MOB)

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.

K261466Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMZeus ScientificK243776Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)Zeus ScientificK172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternEuroimmun Us, Inc.K172461AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinAesku.Diagnostics GmbH & Co. KGK173792EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayPhadia ABK161258NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitInova 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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