The following data is part of a premarket notification filed by Biopool Ab with the FDA for Biopool Vwf Eld Kit And Vwf Eld Bulk Plates.
| Device ID | K942087 |
| 510k Number | K942087 |
| Device Name: | BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES |
| 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 | 1994-05-02 |
| Decision Date | 1995-07-13 |