The following data is part of a premarket notification filed by Biopool Ab with the FDA for Protein S Eid Kit And Protein S Eid Bulk Plates.
Device ID | K915163 |
510k Number | K915163 |
Device Name: | PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES |
Classification | Test, Qualitative And Quantitative Factor Deficiency |
Applicant | BIOPOOL AB 430 YORK BLVD., HAMILTON Ontario L8r 3k8, CA |
Contact | Andrew L Cerskus |
Correspondent | Andrew L Cerskus BIOPOOL AB 430 YORK BLVD., HAMILTON Ontario L8r 3k8, CA |
Product Code | GGP |
CFR Regulation Number | 864.7290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-14 |
Decision Date | 1992-01-06 |