The following data is part of a premarket notification filed by Biopool Ab with the FDA for Minutex D-dimer Latex Test.
| Device ID | K920668 |
| 510k Number | K920668 |
| Device Name: | MINUTEX D-DIMER LATEX TEST |
| Classification | Fibrin Split Products |
| 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 | GHH |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-13 |
| Decision Date | 1992-10-16 |