SPECTROLYSE ANTIPLASMIN KIT— 510(k) K941752

Unknown

Biopool AB

FDA 510(k) clearance K941752 for SPECTROLYSE ANTIPLASMIN KIT, Unknown on 1995-09-25. 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: 1994-04-08
Decision date: 1995-09-25
Decision: Unknown
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.