ALBUMIN TEST

Bromcresol Green Dye-binding, Albumin

KING DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK811662
510k NumberK811662
Device Name:ALBUMIN TEST
ClassificationBromcresol Green Dye-binding, Albumin
Applicant KING DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCIX  
CFR Regulation Number862.1035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-06-15
Decision Date1981-06-25

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