The following data is part of a premarket notification filed by Biopool Ab with the FDA for Spectrolyse Antiplasmin Kit.
| Device ID | K941752 |
| 510k Number | K941752 |
| Device Name: | SPECTROLYSE ANTIPLASMIN KIT |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | BIOPOOL AB 1016 SUTTON DR. UNIT C8, BURLINGTON Ontario, L7l 6b8, CA L7l 6b8 |
| Contact | Andrew L Cerskus |
| Correspondent | Andrew L Cerskus 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 - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-08 |
| Decision Date | 1995-09-25 |