The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Allercoat Allergen Discs.
| Device ID | K852794 |
| 510k Number | K852794 |
| Device Name: | ALLERCOAT ALLERGEN DISCS |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Sue Tesmer |
| Correspondent | Sue Tesmer KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-01 |
| Decision Date | 1985-09-19 |