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 |