CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ

Cresolphthalein Complexone, Calcium

SIMMLER, INC.

The following data is part of a premarket notification filed by Simmler, Inc. with the FDA for Calcium Reagent For Astra 8 Autom Stat/rout/analyz.

Pre-market Notification Details

Device IDK853050
510k NumberK853050
Device Name:CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ
ClassificationCresolphthalein Complexone, Calcium
Applicant SIMMLER, INC. 3755 FOREST PARK AVE. St. Louis,  MO  63108
ContactR. M Boedeker
CorrespondentR. M Boedeker
SIMMLER, INC. 3755 FOREST PARK AVE. St. Louis,  MO  63108
Product CodeCIC  
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-19
Decision Date1985-08-02

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