The following data is part of a premarket notification filed by Biocell Laboratories, Inc. with the FDA for Radial Immunodiffusion Plates.
| Device ID | K830911 |
| 510k Number | K830911 |
| Device Name: | RADIAL IMMUNODIFFUSION PLATES |
| Classification | Transferrin, Antigen, Antiserum, Control |
| Applicant | BIOCELL LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DDG |
| CFR Regulation Number | 866.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-21 |
| Decision Date | 1983-06-10 |