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FDA 510(k)

SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY

K-Number: K980885 · 1998-08-21

ApplicantShield Diagnostics, Ltd.
Decision Date1998-08-21
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SHIELD ACTIVATED FACTOR XII (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 1998-08-21 under 510(k) number K980885. 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 ACTIVATED FACTOR XII (ELISA) ASSAY?

SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY is a medical device that received FDA 510(k) clearance on 1998-08-21. The listed applicant is Shield Diagnostics, Ltd.. The 510(k) number is K980885.

When did SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY receive FDA 510(k) clearance?

SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY received FDA 510(k) clearance on 1998-08-21, under 510(k) number K980885.

Who is the listed applicant for SHIELD ACTIVATED FACTOR XII (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 ACTIVATED FACTOR XII (ELISA) ASSAY?

The FDA product code for SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY 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.

K000398SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200K982879SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (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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