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FDA 510(k)

SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200

K-Number: K000398 · 2000-04-17

ApplicantShield Diagnostics, Ltd.
Decision Date2000-04-17
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 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 2000-04-17 under 510(k) number K000398. 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, MODEL FVWF 200?

SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 is a medical device that received FDA 510(k) clearance on 2000-04-17. The listed applicant is Shield Diagnostics, Ltd.. The 510(k) number is K000398.

When did SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 receive FDA 510(k) clearance?

SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 received FDA 510(k) clearance on 2000-04-17, under 510(k) number K000398.

Who is the listed applicant for SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200?

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, MODEL FVWF 200?

The FDA product code for SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 is GGP.

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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.

K982879SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAYK980885SHIELD ACTIVATED FACTOR XII (ELISA) ASSAYK972981SHIELD HELICO-G2 ELISA KITK962825SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAYK963525DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KITK961515QUANTASE PHENYLALANINE ASSAY

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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.

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