The following data is part of a premarket notification filed by Cooper Biomedical, Inc. with the FDA for Radial Immuno-diffusion Plates Iga, Igd, Igg & Igm.
| Device ID | K851284 |
| 510k Number | K851284 |
| Device Name: | RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM |
| Classification | Iga, 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 | CZP |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-01 |
| Decision Date | 1985-06-11 |