The following data is part of a premarket notification filed by Biopool Intl., Inc. with the FDA for Miniquant D-dimer, Model 1447.
| Device ID | K002642 |
| 510k Number | K002642 |
| Device Name: | MINIQUANT D-DIMER, MODEL 1447 |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | BIOPOOL INTL., INC. 6025 NICOLLE ST. Ventura, CA 93003 |
| Contact | Michael D Bick |
| Correspondent | Michael D Bick BIOPOOL INTL., INC. 6025 NICOLLE ST. Ventura, CA 93003 |
| Product Code | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-24 |
| Decision Date | 2001-02-05 |