The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Allercoat Positive Control Serum.
| Device ID | K823403 |
| 510k Number | K823403 |
| Device Name: | ALLERCOAT POSITIVE CONTROL SERUM |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-15 |
| Decision Date | 1982-12-15 |