STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

Indicator, Biological 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 Steritec Smart-read Biological Test Pack With Instant Readout Integrator.

Pre-market Notification Details

Device IDK111150
510k NumberK111150
Device Name:STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
ClassificationIndicator, Biological Sterilization Process
Applicant STERITEC PRODUCTS MFG. CO., INC. 74 INVERNESS DRIVE EAST Englewood,  CO  80112
ContactJonathan Rutigliano
CorrespondentJonathan Rutigliano
STERITEC PRODUCTS MFG. CO., INC. 74 INVERNESS DRIVE EAST Englewood,  CO  80112
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-25
Decision Date2011-07-08

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