The following data is part of a premarket notification filed by Somas Medical Industries, Inc. with the FDA for Total Iron Uibc/tibc Assay.
Device ID | K840485 |
510k Number | K840485 |
Device Name: | TOTAL IRON UIBC/TIBC ASSAY |
Classification | Bathophenanthroline, Colorimetry, Iron (non-heme) |
Applicant | SOMAS MEDICAL INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CFM |
CFR Regulation Number | 862.1410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-06 |
Decision Date | 1984-03-12 |