The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Ferritin 125i Radioimmunoassay.
Device ID | K830591 |
510k Number | K830591 |
Device Name: | CORNING FERRITIN 125I RADIOIMMUNOASSAY |
Classification | Ferritin, Antigen, Antiserum, Control |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DBF |
CFR Regulation Number | 866.5340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-24 |
Decision Date | 1983-03-24 |