The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quanticlone Ige Radioimmunassay.
| Device ID | K852268 |
| 510k Number | K852268 |
| Device Name: | QUANTICLONE IGE RADIOIMMUNASSAY |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Susan Bieniek |
| Correspondent | Susan Bieniek KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-28 |
| Decision Date | 1985-07-10 |