BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES— 510(k) K942087

Name: FDA 510(k) clearance K942087
Creator: U.S. Food and Drug Administration
Published: 1995-07-13

Substantially Equivalent

Biopool AB

FDA 510(k) clearance K942087 for BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES, Substantially Equivalent on 1995-07-13. Applicant: Biopool AB. Device class: 2.

Clearance details

Applicant: Biopool AB
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1994-05-02
Decision date: 1995-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, L7l 6b8, CA

Download summary PDF View on FDA.gov ↗

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