The following data is part of a premarket notification filed by Dynal Biotech, Inc. with the FDA for Dynabeads Hla Cell Prep Ii Isolation Product.
| Device ID | K873185 |
| 510k Number | K873185 |
| Device Name: | DYNABEADS HLA CELL PREP II ISOLATION PRODUCT |
| Classification | Lymphocyte Separation Medium |
| Applicant | DYNAL BIOTECH, INC. 45 NORTH STATION PLAZA Great Neck, NY 11021 |
| Contact | Barbara A Sawitsky |
| Correspondent | Barbara A Sawitsky DYNAL BIOTECH, INC. 45 NORTH STATION PLAZA Great Neck, NY 11021 |
| Product Code | JCF |
| CFR Regulation Number | 864.8500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-12 |
| Decision Date | 1987-11-04 |