The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Ige/the Ophylline Control Serum I,ii,iii.
| Device ID | K822133 |
| 510k Number | K822133 |
| Device Name: | IGE/THE OPHYLLINE CONTROL SERUM I,II,III |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-20 |
| Decision Date | 1982-08-03 |