SPECTROLYSE/PL PAI KIT— 510(k) K922782

Substantially Equivalent

Biopool AB

FDA 510(k) clearance K922782 for SPECTROLYSE/PL PAI KIT, Substantially Equivalent on 1992-10-09. 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: 1992-06-09
Decision date: 1992-10-09
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.