MULTICHEM ALBUMIN REAGENT S0902

Bromcresol Green Dye-binding, Albumin

SIMMLER, INC.

The following data is part of a premarket notification filed by Simmler, Inc. with the FDA for Multichem Albumin Reagent S0902.

Pre-market Notification Details

Device IDK874049
510k NumberK874049
Device Name:MULTICHEM ALBUMIN REAGENT S0902
ClassificationBromcresol Green Dye-binding, Albumin
Applicant SIMMLER, INC. POST OFFICE BOX 25179 St. Louis,  MO  63125
ContactCrider, Phd
CorrespondentCrider, Phd
SIMMLER, INC. POST OFFICE BOX 25179 St. Louis,  MO  63125
Product CodeCIX  
CFR Regulation Number862.1035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-05
Decision Date1987-10-29

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