The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Radioassay, Control Serum I, Ii, Iii.
Device ID | K790298 |
510k Number | K790298 |
Device Name: | RADIOASSAY, CONTROL SERUM I, II, III |
Classification | Whole Human Serum, Antigen, Antiserum, Control |
Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DGR |
CFR Regulation Number | 866.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-02-12 |
Decision Date | 1979-04-04 |