STERICHEK PERACETIC ACID REAGENT STRIPS

Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

ENVIRONMENTAL TEST SYSTEMS, INC.

The following data is part of a premarket notification filed by Environmental Test Systems, Inc. with the FDA for Sterichek Peracetic Acid Reagent Strips.

Pre-market Notification Details

Device IDK980164
510k NumberK980164
Device Name:STERICHEK PERACETIC ACID REAGENT STRIPS
ClassificationStrip, Test, Reagent, Residuals For Dialysate, Disinfectant
Applicant ENVIRONMENTAL TEST SYSTEMS, INC. P.O. BOX 4659 Elkhart,  IN  46514
ContactBruce G Piekarski
CorrespondentBruce G Piekarski
ENVIRONMENTAL TEST SYSTEMS, INC. P.O. BOX 4659 Elkhart,  IN  46514
Product CodeMSY  
CFR Regulation Number876.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-16
Decision Date1998-04-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851575007150 K980164 000
00898021000242 K980164 000

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