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FDA 510(k)

WIELISA MPO ANCA TEST SYSTEM

K-Number: K974166 · 1998-02-17

ApplicantWieslab AB
Decision Date1998-02-17
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

WIELISA MPO ANCA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wieslab AB. It received FDA 510(k) clearance on 1998-02-17 under 510(k) number K974166. 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 WIELISA MPO ANCA TEST SYSTEM?

WIELISA MPO ANCA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1998-02-17. The listed applicant is Wieslab AB. The 510(k) number is K974166.

When did WIELISA MPO ANCA TEST SYSTEM receive FDA 510(k) clearance?

WIELISA MPO ANCA TEST SYSTEM received FDA 510(k) clearance on 1998-02-17, under 510(k) number K974166.

Who is the listed applicant for WIELISA MPO ANCA TEST SYSTEM?

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

What is the FDA product code for WIELISA MPO ANCA TEST SYSTEM?

The FDA product code for WIELISA MPO ANCA TEST SYSTEM is MOB.

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Other records listing Wieslab AB 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.

K981748WIELISA ANCA SCREENING KIT TEST SYSTEMK981750WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEMK974167WIELISA PR-3 ANCA TEST SYSTEMK974169WIELISA ANTI-GBM TEST SYSTEM

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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