TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2

Biuret (colorimetric), Total Protein

EMD CHEMICALS INC.

The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Total Protein Test (tpro) Item Number: Xxxxx/r1. R2.

Pre-market Notification Details

Device IDK950234
510k NumberK950234
Device Name:TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2
ClassificationBiuret (colorimetric), Total Protein
Applicant EMD CHEMICALS INC. DIV. OF EM INDUSTRIES INC. 480 DEMOCRAT RD. Gibbstown,  NJ  08027
ContactCarol Faulkner
CorrespondentCarol Faulkner
EMD CHEMICALS INC. DIV. OF EM INDUSTRIES INC. 480 DEMOCRAT RD. Gibbstown,  NJ  08027
Product CodeCEK  
CFR Regulation Number862.1635 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-13
Decision Date1995-06-14

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