The following data is part of a premarket notification filed by Biopool Ab with the FDA for Spectrolyse Protein C Kit.
Device ID | K914307 |
510k Number | K914307 |
Device Name: | SPECTROLYSE PROTEIN C KIT |
Classification | Test, Qualitative And Quantitative Factor Deficiency |
Applicant | BIOPOOL AB 1016 SUTTON DR. UNIT C8, BURLINGTON Ontario, L7l 6b8, CA L7l 6b8 |
Contact | Andrew L Cerskus |
Correspondent | Andrew L Cerskus BIOPOOL AB 1016 SUTTON DR. UNIT C8, BURLINGTON Ontario, L7l 6b8, CA L7l 6b8 |
Product Code | GGP |
CFR Regulation Number | 864.7290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-25 |
Decision Date | 1991-12-09 |