The following data is part of a premarket notification filed by Biopool Intl., Inc. with the FDA for I-stat Coagulation Control Set.
| Device ID | K981752 |
| 510k Number | K981752 |
| Device Name: | I-STAT COAGULATION CONTROL SET |
| Classification | Plasma, Coagulation 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 | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-18 |
| Decision Date | 1998-06-15 |