The following data is part of a premarket notification filed by Biopool Ab with the FDA for Spectrolyse Heparin Kit.
Device ID | K923499 |
510k Number | K923499 |
Device Name: | SPECTROLYSE HEPARIN KIT |
Classification | Assay, Heparin |
Applicant | BIOPOOL AB 1016 SUTTON DR. UNIT C8, BURLINGTON Ontario, L7l 6b8, CA L7l 6b8 |
Contact | Anderw L Cerskus |
Correspondent | Anderw L Cerskus BIOPOOL AB 1016 SUTTON DR. UNIT C8, BURLINGTON Ontario, L7l 6b8, CA L7l 6b8 |
Product Code | KFF |
CFR Regulation Number | 864.7525 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-15 |
Decision Date | 1994-01-27 |