Strep B Carrot Broth Kit

Gbs Culture Media, Selective And Differential

Hardy Diagnostics

The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Strep B Carrot Broth Kit.

Pre-market Notification Details

Device IDK170481
510k NumberK170481
Device Name:Strep B Carrot Broth Kit
ClassificationGbs Culture Media, Selective And Differential
Applicant Hardy Diagnostics 1430 West McCoy Lane Santa Maria,  CA  93455
ContactRianna Malherbe
CorrespondentRianna Malherbe
Hardy Diagnostics 1430 West McCoy Lane Santa Maria,  CA  93455
Product CodePQZ  
CFR Regulation Number866.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-16
Decision Date2017-05-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10819398020579 K170481 000

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