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FDA 510(k)

COATEST FACTOR VIII

K-Number: K833892 · 1984-01-30

ApplicantKabivitrum, Inc.
Decision Date1984-01-30
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COATEST FACTOR VIII is the device name listed in this FDA 510(k) record. The listed applicant is Kabivitrum, Inc.. It received FDA 510(k) clearance on 1984-01-30 under 510(k) number K833892. 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 COATEST FACTOR VIII?

COATEST FACTOR VIII is a medical device that received FDA 510(k) clearance on 1984-01-30. The listed applicant is Kabivitrum, Inc.. The 510(k) number is K833892.

When did COATEST FACTOR VIII receive FDA 510(k) clearance?

COATEST FACTOR VIII received FDA 510(k) clearance on 1984-01-30, under 510(k) number K833892.

Who is the listed applicant for COATEST FACTOR VIII?

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

What is the FDA product code for COATEST FACTOR VIII?

The FDA product code for COATEST FACTOR VIII is GGP.

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Other records listing Kabivitrum, Inc. 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.

K884058COATEST PROTEIN CK854572COATEST PLASMINOGENK844664THE I.V. BAGK833890COATEST ANTIPLASMINK833891COATEST HEPARINK832114COATEST FACTOR X

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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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