The following data is part of a premarket notification filed by Biopool Intl., Inc. with the FDA for Bioclot Apc Sensitivity.
| Device ID | K983898 |
| 510k Number | K983898 |
| Device Name: | BIOCLOT APC SENSITIVITY |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| 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 | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-03 |
| Decision Date | 1999-01-06 |