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 |