Sensititre 20-24 Hour Haemophilus Influenzae /Streptococcus Pneumoniae MIC Or Breakpoint Susceptibility System With Dtest (containing Erythromycin At 1 Ug/mL And Clindamycin At 0.5 Ug/mL)

Manual Antimicrobial Susceptibility Test Systems

Thermo Fisher Scientific

The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Sensititre 20-24 Hour Haemophilus Influenzae /streptococcus Pneumoniae Mic Or Breakpoint Susceptibility System With Dtest (containing Erythromycin At 1 Ug/ml And Clindamycin At 0.5 Ug/ml).

Pre-market Notification Details

Device IDK202612
510k NumberK202612
Device Name:Sensititre 20-24 Hour Haemophilus Influenzae /Streptococcus Pneumoniae MIC Or Breakpoint Susceptibility System With Dtest (containing Erythromycin At 1 Ug/mL And Clindamycin At 0.5 Ug/mL)
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant Thermo Fisher Scientific One Thermo Fisher Way Oakwood Village,  OH  44146
ContactCynthia Knapp
CorrespondentCynthia Knapp
Thermo Fisher Scientific One Thermo Fisher Way Oakwood Village,  OH  44146
Product CodeJWY  
Subsequent Product CodeLRG
Subsequent Product CodeLTT
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-09
Decision Date2021-07-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05032384571710 K202612 000

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