TOTAL PROTEIN TEST

Biuret (colorimetric), Total Protein

KING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for Total Protein Test.

Pre-market Notification Details

Device IDK811673
510k NumberK811673
Device Name:TOTAL PROTEIN TEST
ClassificationBiuret (colorimetric), Total Protein
Applicant KING DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCEK  
CFR Regulation Number862.1635 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-06-15
Decision Date1981-06-25

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