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FDA 510(k)

VARELISA PR3 ANCA, MODEL NUMBER 17748/17796

K-Number: K041043 · 2004-07-02

ApplicantPharmacia Deutschland GmbH
Decision Date2004-07-02
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 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 2004-07-02 under 510(k) number K041043. 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 PR3 ANCA, MODEL NUMBER 17748/17796?

VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 is a medical device that received FDA 510(k) clearance on 2004-07-02. The listed applicant is Pharmacia Deutschland GmbH. The 510(k) number is K041043.

When did VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 receive FDA 510(k) clearance?

VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 received FDA 510(k) clearance on 2004-07-02, under 510(k) number K041043.

Who is the listed applicant for VARELISA PR3 ANCA, MODEL NUMBER 17748/17796?

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 PR3 ANCA, MODEL NUMBER 17748/17796?

The FDA product code for VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 is MOB.

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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.

K040810VARELISA HISTONE ANTIBODIES, MODEL 16496K040811VARELISA SSDNA ANTIBODIES, MODEL 14896K040449VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796K040451VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896K040452VARELISA 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: 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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