The following data is part of a premarket notification filed by Union Carbide Corp. with the FDA for Centria Ferritin Ria.
Device ID | K792449 |
510k Number | K792449 |
Device Name: | CENTRIA FERRITIN RIA |
Classification | Ferritin, Antigen, Antiserum, Control |
Applicant | UNION CARBIDE CORP. 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 | 1979-11-30 |
Decision Date | 1979-12-31 |