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FDA 510(k)

WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM

K-Number: K981750 · 1998-07-22

ApplicantWieslab AB
Decision Date1998-07-22
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

WIELISA ANTI-GBM, ANCA SCREENING KIT 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 1998-07-22 under 510(k) number K981750. 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 ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM?

WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1998-07-22. The listed applicant is Wieslab AB. The 510(k) number is K981750.

When did WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM receive FDA 510(k) clearance?

WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM received FDA 510(k) clearance on 1998-07-22, under 510(k) number K981750.

Who is the listed applicant for WIELISA ANTI-GBM, ANCA SCREENING KIT 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 ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM?

The FDA product code for WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM is MOB.

Related Clinical Trials

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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 SYSTEMK974167WIELISA PR-3 ANCA TEST SYSTEMK974169WIELISA ANTI-GBM TEST SYSTEMK974166WIELISA MPO ANCA 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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