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 |