PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES— 510(k) K915163

Name: FDA 510(k) clearance K915163
Creator: U.S. Food and Drug Administration
Published: 1992-01-06

Substantially Equivalent

Biopool AB

FDA 510(k) clearance K915163 for PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES, Substantially Equivalent on 1992-01-06. 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: 1991-11-14
Decision date: 1992-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario L8r 3k8, CA

Download summary PDF View on FDA.gov ↗

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