The following data is part of a premarket notification filed by Biopool Ab with the FDA for Spectrolyse Atiii Kit.
Device ID | K902530 |
510k Number | K902530 |
Device Name: | SPECTROLYSE ATIII KIT |
Classification | Antithrombin Iii Quantitation |
Applicant | BIOPOOL AB 1016 SUTTON DR. UNIT C8, BURLINGTON Ontario, L7l 6b8, CA L7l 6b8 |
Contact | Cerskus, Phd |
Correspondent | Cerskus, Phd BIOPOOL AB 1016 SUTTON DR. UNIT C8, BURLINGTON Ontario, L7l 6b8, CA L7l 6b8 |
Product Code | JBQ |
CFR Regulation Number | 864.7060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-05 |
Decision Date | 1990-08-09 |