The following data is part of a premarket notification filed by Kelleher Corp. with the FDA for Nystymograph Access.
| Device ID | K823111 |
| 510k Number | K823111 |
| Device Name: | NYSTYMOGRAPH ACCESS |
| Classification | Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6 |
| Applicant | KELLEHER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GNN |
| CFR Regulation Number | 866.3145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-25 |
| Decision Date | 1982-11-22 |