FDA 510(k)

COATEST ANTITHROMBIN

K-Number: K812829 · 1981-12-30

Decision Date1981-12-30

Product CodeJBQ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

COATEST ANTITHROMBIN is the device name listed in this FDA 510(k) record. The listed applicant is Kabivitrum, Inc.. It received FDA 510(k) clearance on 1981-12-30 under 510(k) number K812829. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COATEST ANTITHROMBIN?

COATEST ANTITHROMBIN is a medical device that received FDA 510(k) clearance on 1981-12-30. The listed applicant is Kabivitrum, Inc.. The 510(k) number is K812829.

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

COATEST ANTITHROMBIN received FDA 510(k) clearance on 1981-12-30, under 510(k) number K812829.

Who is the listed applicant for COATEST ANTITHROMBIN?

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 ANTITHROMBIN?

The FDA product code for COATEST ANTITHROMBIN is JBQ.

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Other records listing Kabivitrum, Inc. as applicant

K884058COATEST PROTEIN C K854572COATEST PLASMINOGEN K844664THE I.V. BAG K833890COATEST ANTIPLASMIN K833891COATEST HEPARIN K833892COATEST FACTOR VIII

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Related Devices (Code: JBQ)

K242952INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbH K081769INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5Siemens Healthcare Diagnostics K070301HEMOSIL ANTITHROMBINInstrumentation Laboratory CO K062431HEMOSIL LIQUID ANTITHROMBINInstrumentation Laboratory CO K043007BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105Hyphen Biomed K033775HEMOSIL LIQUID ANTITHROMBIN XLInstrumentation 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.