The following data is part of a premarket notification filed by Icl Scientific with the FDA for Electro-immuno-quantitation (eiq).
Device ID | K792472 |
510k Number | K792472 |
Device Name: | ELECTRO-IMMUNO-QUANTITATION (EIQ) |
Classification | Complement C1q, Antigen, Antiserum, Control |
Applicant | ICL SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DAK |
CFR Regulation Number | 866.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-03 |
Decision Date | 1979-12-27 |