The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Kallestad Quantitope Low Level Ige Reag.
Device ID | K811545 |
510k Number | K811545 |
Device Name: | KALLESTAD QUANTITOPE LOW LEVEL IGE REAG |
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 | 1981-06-01 |
Decision Date | 1981-06-24 |