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 |