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FDA 510(k)

HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY

K-Number: K930235 · 1993-09-02

ApplicantTechnidyne Corp.
Decision Date1993-09-02
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Technidyne Corp.. It received FDA 510(k) clearance on 1993-09-02 under 510(k) number K930235. 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 HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY?

HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY is a medical device that received FDA 510(k) clearance on 1993-09-02. The listed applicant is Technidyne Corp.. The 510(k) number is K930235.

When did HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY receive FDA 510(k) clearance?

HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY received FDA 510(k) clearance on 1993-09-02, under 510(k) number K930235.

Who is the listed applicant for HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY?

The FDA 510(k) record lists Technidyne Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY?

The FDA product code for HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY is GGP.

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Other records listing Technidyne Corp. 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.

K930068HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION

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

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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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