The following data is part of a premarket notification filed by Icl Scientific with the FDA for Aim System (for Igm).
Device ID | K811124 |
510k Number | K811124 |
Device Name: | AIM SYSTEM (FOR IGM) |
Classification | Igm, Antigen, Antiserum, Control |
Applicant | ICL SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DFT |
CFR Regulation Number | 866.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-24 |
Decision Date | 1981-05-08 |