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FDA 510(k)

BOVINE FACTOR XA-HUMAN FACTOR XA

K-Number: K841957 · 1984-07-19

ApplicantHaemachem, Inc.
Decision Date1984-07-19
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BOVINE FACTOR XA-HUMAN FACTOR XA is the device name listed in this FDA 510(k) record. The listed applicant is Haemachem, Inc.. It received FDA 510(k) clearance on 1984-07-19 under 510(k) number K841957. 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 BOVINE FACTOR XA-HUMAN FACTOR XA?

BOVINE FACTOR XA-HUMAN FACTOR XA is a medical device that received FDA 510(k) clearance on 1984-07-19. The listed applicant is Haemachem, Inc.. The 510(k) number is K841957.

When did BOVINE FACTOR XA-HUMAN FACTOR XA receive FDA 510(k) clearance?

BOVINE FACTOR XA-HUMAN FACTOR XA received FDA 510(k) clearance on 1984-07-19, under 510(k) number K841957.

Who is the listed applicant for BOVINE FACTOR XA-HUMAN FACTOR XA?

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

What is the FDA product code for BOVINE FACTOR XA-HUMAN FACTOR XA?

The FDA product code for BOVINE FACTOR XA-HUMAN FACTOR XA is GGP.

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Other records listing Haemachem, 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.

K903874FIBRINOTEST(TM) - FIBRINOGEN ASSAYK853239HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAYK841956BOVINE THROMBIN, HUMAN THROMBIN

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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