The following data is part of a premarket notification filed by Cooper Biomedical, Inc. with the FDA for Radial Immunodiffusion Plates Alpha-2 Macroglobuli.
| Device ID | K851282 |
| 510k Number | K851282 |
| Device Name: | RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI |
| Classification | Alpha-2-macroglobulin, Antigen, Antiserum, Control |
| Applicant | COOPER BIOMEDICAL, INC. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Contact | Amiram Daniel |
| Correspondent | Amiram Daniel COOPER BIOMEDICAL, INC. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Product Code | DEB |
| CFR Regulation Number | 866.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-01 |
| Decision Date | 1985-05-24 |