SPECTROLYSE HEPARIN KIT— 510(k) K923499
Substantially EquivalentBiopool AB
FDA 510(k) clearance K923499 for SPECTROLYSE HEPARIN KIT, Substantially Equivalent on 1994-01-27. Applicant: Biopool AB. Device class: 2.
Clearance details
- Applicant
- Biopool AB
- Product code
- Code KFF
- Device class
- Class 2
- Regulation
- 21 CFR 864.7525
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ontario, L7l 6b8, CA
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