The following data is part of a premarket notification filed by Kent Laboratories, Inc. with the FDA for 72 Determin. Size Radial Immunod. Test.
| Device ID | K811613 |
| 510k Number | K811613 |
| Device Name: | 72 DETERMIN. SIZE RADIAL IMMUNOD. TEST |
| Classification | Transferrin, Antigen, Antiserum, Control |
| Applicant | KENT 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 | 1981-06-08 |
| Decision Date | 1981-08-12 |