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FDA 510(k)

COATEST HEPARIN

K-Number: K833891 · 1984-01-30

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

Device Summary

COATEST HEPARIN 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 K833891. The device is classified under product code KFF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COATEST HEPARIN?

COATEST HEPARIN 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 K833891.

When did COATEST HEPARIN receive FDA 510(k) clearance?

COATEST HEPARIN received FDA 510(k) clearance on 1984-01-30, under 510(k) number K833891.

Who is the listed applicant for COATEST HEPARIN?

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 HEPARIN?

The FDA product code for COATEST HEPARIN is KFF.

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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 ANTIPLASMINK833892COATEST FACTOR VIIIK832114COATEST FACTOR X

View all 8 devices →

Related Devices (Code: KFF)

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.

K260214STA® - Liquid Anti-XaDiagnostica Stago, Inc.K213464HemosIL Liquid Anti-XaInstrumentation Laboratory COK162540INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW ControlsSiemens Healthcare Diagnostics Prodcts GmbHK111822STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWHDiagnostica Stago, Inc.K090209HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLSInstrumentation Laboratory COK050367BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6Hyphen Biomed

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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