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FDA 510(k)

WIESLAB CAP PR-3 ANCA

K-Number: K051458 · 2005-11-22

ApplicantEurodiagnostica
Decision Date2005-11-22
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

WIESLAB CAP PR-3 ANCA is the device name listed in this FDA 510(k) record. The listed applicant is Eurodiagnostica. It received FDA 510(k) clearance on 2005-11-22 under 510(k) number K051458. 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 WIESLAB CAP PR-3 ANCA?

WIESLAB CAP PR-3 ANCA is a medical device that received FDA 510(k) clearance on 2005-11-22. The listed applicant is Eurodiagnostica. The 510(k) number is K051458.

When did WIESLAB CAP PR-3 ANCA receive FDA 510(k) clearance?

WIESLAB CAP PR-3 ANCA received FDA 510(k) clearance on 2005-11-22, under 510(k) number K051458.

Who is the listed applicant for WIESLAB CAP PR-3 ANCA?

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

What is the FDA product code for WIESLAB CAP PR-3 ANCA?

The FDA product code for WIESLAB CAP PR-3 ANCA is MOB.

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Other records listing Eurodiagnostica 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.

K052133IMMUNOSCAN RA ANTI-CCP TEST SYSTEMK051455WIESLAB CAP MPO-ANCA

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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