FDA.reportPublic FDA data

510(k) K170586

Device
Strep B Carrot Broth One-Step
Applicant
Hardy Diagnostics
510(k) number
K170586
Product code
PQZ  
Decision
Substantially Equivalent (SESE)
Decision date
2017-05-22
Date received
2017-02-28
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
Christopher Massey
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
K170481Strep B Carrot Broth KitHardy Diagnostics2017-05-16
K163042chromID Strepto B agarbioMerieux, Inc.2017-01-27

Legacy Summary#

summary

FDA Review#

Decision Summary