CALCIUM REAGENT SYS

Di (o-hydroxyphenylimine) Ethane, Calcium

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Calcium Reagent Sys.

Pre-market Notification Details

Device IDK840214
510k NumberK840214
Device Name:CALCIUM REAGENT SYS
ClassificationDi (o-hydroxyphenylimine) Ethane, Calcium
Applicant SCLAVO, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCHZ  
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-01-19
Decision Date1984-03-19

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