BOVINE FACTOR XA-HUMAN FACTOR XA— 510(k) K841957

Name: FDA 510(k) clearance K841957
Creator: U.S. Food and Drug Administration
Published: 1984-07-19

Substantially Equivalent

Haemachem, Inc.

FDA 510(k) clearance K841957 for BOVINE FACTOR XA-HUMAN FACTOR XA, Substantially Equivalent on 1984-07-19. Applicant: Haemachem, Inc.. Device class: 2.

Clearance details

Applicant: Haemachem, Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1984-05-14
Decision date: 1984-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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