COATEST ANTITHROMBIN— 510(k) K812829

Substantially Equivalent

Kabivitrum, Inc.

FDA 510(k) clearance K812829 for COATEST ANTITHROMBIN, Substantially Equivalent on 1981-12-30. Applicant: Kabivitrum, Inc.. Device class: 2.

Clearance details

Applicant: Kabivitrum, Inc.
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1981-10-08
Decision date: 1981-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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