BIOCLOT LA— 510(k) K932463

Substantially Equivalent

Biopool AB

FDA 510(k) clearance K932463 for BIOCLOT LA, Substantially Equivalent on 1993-09-27. Applicant: Biopool AB. Device class: 1.

Clearance details

Applicant: Biopool AB
Product code: Code GIR
Device class: Class 1
Regulation: 21 CFR 864.8950
Advisory panel: Hematology
Date received: 1993-05-21
Decision date: 1993-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, L7l 6b8, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.