CIDEX OPA SOLUTION TEST STRIP

Indicator, Physical/chemical Sterilization Process

SERIM RESEARCH CORP.

The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Cidex Opa Solution Test Strip.

Pre-market Notification Details

Device IDK992341
510k NumberK992341
Device Name:CIDEX OPA SOLUTION TEST STRIP
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant SERIM RESEARCH CORP. 23565 REEDY DR. Elkhart,  IN  46514
ContactJames E Christner
CorrespondentJames E Christner
SERIM RESEARCH CORP. 23565 REEDY DR. Elkhart,  IN  46514
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-13
Decision Date1999-11-23
Summary:summary

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