The following data is part of a premarket notification filed by Cooper Biomedical, Inc. with the FDA for Leap Le Test Kit.
| Device ID | K842484 |
| 510k Number | K842484 |
| Device Name: | LEAP LE TEST KIT |
| Classification | Antinuclear Antibody, Antigen, Control |
| Applicant | COOPER BIOMEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-25 |
| Decision Date | 1984-07-11 |