The following data is part of a premarket notification filed by Biopool Ab with the FDA for Spectrolyse Atiii Kit.
| Device ID | K902530 |
| 510k Number | K902530 |
| Device Name: | SPECTROLYSE ATIII KIT |
| Classification | Antithrombin Iii Quantitation |
| Applicant | BIOPOOL AB 1016 SUTTON DR. UNIT C8, BURLINGTON Ontario, L7l 6b8, CA L7l 6b8 |
| Contact | Cerskus, Phd |
| Correspondent | Cerskus, Phd BIOPOOL AB 1016 SUTTON DR. UNIT C8, BURLINGTON Ontario, L7l 6b8, CA L7l 6b8 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-05 |
| Decision Date | 1990-08-09 |