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510(k) K170481

Device
Strep B Carrot Broth Kit
Applicant
Hardy Diagnostics
510(k) number
K170481
Product code
PQZ  
Decision
Substantially Equivalent (SESE)
Decision date
2017-05-16
Date received
2017-02-16
Regulation
866.2360
Classification name
Gbs Culture Media, Selective And Differential
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Rianna Malherbe
Address
1430 W. Mccoy Ln. Santa Maria CA US 93455 93455

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PQZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K173903Granada MediumHardy Diagnostics2018-03-22
K170586Strep B Carrot Broth One-StepHardy Diagnostics2017-05-22
K163042chromID Strepto B agarbioMerieux, Inc.2017-01-27

Legacy Summary#

summary

FDA Review#

Decision Summary