The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Cornings Magic Ferritin Radioimmuno-.
Device ID | K840460 |
510k Number | K840460 |
Device Name: | CORNINGS MAGIC FERRITIN RADIOIMMUNO- |
Classification | Radioimmunoassay (two-site Solid Phase), Ferritin |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JMG |
CFR Regulation Number | 866.5340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-02 |
Decision Date | 1984-03-30 |