The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Allercoat Allergen Discs.
Device ID | K831326 |
510k Number | K831326 |
Device Name: | ALLERCOAT ALLERGEN DISCS |
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 | 1983-04-25 |
Decision Date | 1983-06-02 |