MIDAS 100 HEMACOLOR STAIN #66030

Eosin Y

EMD CHEMICALS INC.

The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Midas 100 Hemacolor Stain #66030.

Pre-market Notification Details

Device IDK822982
510k NumberK822982
Device Name:MIDAS 100 HEMACOLOR STAIN #66030
ClassificationEosin Y
Applicant EMD CHEMICALS INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHYB  
CFR Regulation Number864.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-10-08
Decision Date1982-10-27

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