COATEST FACTOR X— 510(k) K832114

Substantially Equivalent

Kabivitrum, Inc.

FDA 510(k) clearance K832114 for COATEST FACTOR X, Substantially Equivalent on 1983-08-26. Applicant: Kabivitrum, Inc.. Device class: 2.

Clearance details

Applicant: Kabivitrum, Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1983-06-30
Decision date: 1983-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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