COATEST PROTEIN C— 510(k) K884058

Substantially Equivalent

Kabivitrum, Inc.

FDA 510(k) clearance K884058 for COATEST PROTEIN C, Substantially Equivalent on 1988-12-13. 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: 1988-09-26
Decision date: 1988-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alameda, CA, US

Download summary PDF View on FDA.gov ↗

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