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FDA 510(k)

IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT

K-Number: K971464 · 1997-10-29

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

Device Summary

IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT 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 K971464. The device is classified under product code DBL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT?

IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT 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 K971464.

When did IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT receive FDA 510(k) clearance?

IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT received FDA 510(k) clearance on 1997-10-29, under 510(k) number K971464.

Who is the listed applicant for IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT?

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 ANTI-GBM QUANTITATIVE KIT?

The FDA product code for IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT is DBL.

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 KITK971690IMMUNOSCAN PR3-ANCA

Related Devices (Code: DBL)

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.

K180202Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.K980312NOVA LITE ENDOMYSIALInova Diagnostics, Inc.K974169WIELISA ANTI-GBM TEST SYSTEMWieslab ABK971658MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KITJay H. GellerK963525DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KITShield Diagnostics, Ltd.K955431RIT LIVER, KIDNEY, STOMACH IFA KITThe Binding Site, Ltd.

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.

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