SMART READ BIOLOGICAL TEST PACK

Indicator, Physical/chemical Sterilization Process

STERITEC PRODUCTS MFG. CO., INC.

The following data is part of a premarket notification filed by Steritec Products Mfg. Co., Inc. with the FDA for Smart Read Biological Test Pack.

Pre-market Notification Details

Device IDK103000
510k NumberK103000
Device Name:SMART READ BIOLOGICAL TEST PACK
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant STERITEC PRODUCTS MFG. CO., INC. 74 INVERNESS DRIVE EAST Englewood,  CO  80112
ContactSuzanne Dennis
CorrespondentSuzanne Dennis
STERITEC PRODUCTS MFG. CO., INC. 74 INVERNESS DRIVE EAST Englewood,  CO  80112
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-08
Decision Date2011-02-11

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