SERUM IRON & TIBC#65084 & 65085

Photometric Method, Iron (non-heme)

EMD CHEMICALS INC.

The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Serum Iron & Tibc#65084 & 65085.

Pre-market Notification Details

Device IDK833017
510k NumberK833017
Device Name:SERUM IRON & TIBC#65084 & 65085
ClassificationPhotometric Method, Iron (non-heme)
Applicant EMD CHEMICALS INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJIY  
CFR Regulation Number862.1410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-06
Decision Date1983-11-03

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