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FDA 510(k)

IMMUNOSCAN PR3-ANCA

K-Number: K971690 · 1997-10-29

ApplicantEuro-Diagnostica AB
Decision Date1997-10-29
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOSCAN PR3-ANCA is the device name listed in this FDA 510(k) record. The listed applicant is Euro-Diagnostica AB. It received FDA 510(k) clearance on 1997-10-29 under 510(k) number K971690. 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 IMMUNOSCAN PR3-ANCA?

IMMUNOSCAN PR3-ANCA is a medical device that received FDA 510(k) clearance on 1997-10-29. The listed applicant is Euro-Diagnostica AB. The 510(k) number is K971690.

When did IMMUNOSCAN PR3-ANCA receive FDA 510(k) clearance?

IMMUNOSCAN PR3-ANCA received FDA 510(k) clearance on 1997-10-29, under 510(k) number K971690.

Who is the listed applicant for IMMUNOSCAN PR3-ANCA?

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

What is the FDA product code for IMMUNOSCAN PR3-ANCA?

The FDA product code for IMMUNOSCAN PR3-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 Euro-Diagnostica 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.

K093908CCPOINTK091657IMMUNOSCAN CCPLUSK062045EDIA ANTI-CCPK971689IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KITK971464IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT

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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