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)

SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY

K-Number: K962825 · 1996-11-15

ApplicantShield Diagnostics, Ltd.
Decision Date1996-11-15
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Shield Diagnostics, Ltd.. It received FDA 510(k) clearance on 1996-11-15 under 510(k) number K962825. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY?

SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY is a medical device that received FDA 510(k) clearance on 1996-11-15. The listed applicant is Shield Diagnostics, Ltd.. The 510(k) number is K962825.

When did SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY receive FDA 510(k) clearance?

SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY received FDA 510(k) clearance on 1996-11-15, under 510(k) number K962825.

Who is the listed applicant for SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY?

The FDA 510(k) record lists Shield Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY?

The FDA product code for SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY is GGP.

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 Shield Diagnostics, Ltd. 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.

K000398SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200K982879SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAYK980885SHIELD ACTIVATED FACTOR XII (ELISA) ASSAYK972981SHIELD HELICO-G2 ELISA KITK963525DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KITK961515QUANTASE PHENYLALANINE ASSAY

View all 27 devices →

Related Devices (Code: GGP)

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.

K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory CompanyK220728vWF AgSiemens Healthcare Diagnostics Products GmbHK214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory COK200033HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO

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.

↑