The following data is part of a premarket notification filed by Biopool Ab with the FDA for Spectrolyse Plasminogen Sk Kit.
| Device ID | K912025 |
| 510k Number | K912025 |
| Device Name: | SPECTROLYSE PLASMINOGEN SK KIT |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | BIOPOOL AB 1016 SUTTON DR. UNIT C8, BURLINGTON Ontario, L7l 6b8, CA L7l 6b8 |
| Contact | Barbara A Killackey |
| Correspondent | Barbara A Killackey BIOPOOL AB 1016 SUTTON DR. UNIT C8, BURLINGTON Ontario, L7l 6b8, CA L7l 6b8 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-07 |
| Decision Date | 1991-08-22 |