Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

WIESLAB CAP MPO-ANCA

K-Number: K051455 · 2005-11-23

ApplicantEurodiagnostica
Decision Date2005-11-23
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

WIESLAB CAP MPO-ANCA is the device name listed in this FDA 510(k) record. The listed applicant is Eurodiagnostica. It received FDA 510(k) clearance on 2005-11-23 under 510(k) number K051455. 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 MPO-ANCA?

WIESLAB CAP MPO-ANCA is a medical device that received FDA 510(k) clearance on 2005-11-23. The listed applicant is Eurodiagnostica. The 510(k) number is K051455.

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

WIESLAB CAP MPO-ANCA received FDA 510(k) clearance on 2005-11-23, under 510(k) number K051455.

Who is the listed applicant for WIESLAB CAP MPO-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 MPO-ANCA?

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

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK051458WIESLAB CAP PR-3 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

View on FDA Database →

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

↑