TOTAL IRON UIBC/TIBC ASSAY

Bathophenanthroline, Colorimetry, Iron (non-heme)

SOMAS MEDICAL INDUSTRIES, INC.

The following data is part of a premarket notification filed by Somas Medical Industries, Inc. with the FDA for Total Iron Uibc/tibc Assay.

Pre-market Notification Details

Device IDK840485
510k NumberK840485
Device Name:TOTAL IRON UIBC/TIBC ASSAY
ClassificationBathophenanthroline, Colorimetry, Iron (non-heme)
Applicant SOMAS MEDICAL INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCFM  
CFR Regulation Number862.1410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-06
Decision Date1984-03-12

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