Strep B Carrot Broth One-Step
K-Number: K170586 · 2017-05-22
ApplicantHardy Diagnostics
Decision Date2017-05-22
Product CodePQZ
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Strep B Carrot Broth One-Step is a medical device manufactured by Hardy Diagnostics. It received FDA 510(k) clearance on 2017-05-22 under approval number K170586. The device is classified under product code PQZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Strep B Carrot Broth One-Step?
Strep B Carrot Broth One-Step is a medical device that received FDA 510(k) clearance on 2017-05-22. It is manufactured by Hardy Diagnostics. The 510(k) number is K170586.
When was Strep B Carrot Broth One-Step approved by the FDA?
Strep B Carrot Broth One-Step received FDA 510(k) clearance on 2017-05-22, under approval number K170586.
What company makes Strep B Carrot Broth One-Step?
Strep B Carrot Broth One-Step is manufactured by Hardy Diagnostics.
What is the FDA product code for Strep B Carrot Broth One-Step?
The FDA product code for Strep B Carrot Broth One-Step is PQZ.
Other Devices by Hardy Diagnostics
Related Devices (Code: PQZ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.