FDA 510(k)

Strep B Carrot Broth Kit

K-Number: K170481 · 2017-05-16

Decision Date2017-05-16

Product CodePQZ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Strep B Carrot Broth Kit is a medical device manufactured by Hardy Diagnostics. It received FDA 510(k) clearance on 2017-05-16 under approval number K170481. 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 Kit?

Strep B Carrot Broth Kit is a medical device that received FDA 510(k) clearance on 2017-05-16. It is manufactured by Hardy Diagnostics. The 510(k) number is K170481.

When was Strep B Carrot Broth Kit approved by the FDA?

Strep B Carrot Broth Kit received FDA 510(k) clearance on 2017-05-16, under approval number K170481.

What company makes Strep B Carrot Broth Kit?

Strep B Carrot Broth Kit is manufactured by Hardy Diagnostics.

What is the FDA product code for Strep B Carrot Broth Kit?

The FDA product code for Strep B Carrot Broth Kit is PQZ.

Other Devices by Hardy Diagnostics

K160512HardyCHROM ESBL K172621HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) K171975HardyDisk AST Delafloxacin 5 µg (DLX5) K170586Strep B Carrot Broth One-Step K170127HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 K182357HardyDisk AST Eravacycline 20µg (ERV20)

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Related Devices (Code: PQZ)

K170586Strep B Carrot Broth One-StepHardy Diagnostics K163042chromID Strepto B agarbioMerieux, Inc. K173903Granada MediumHardy Diagnostics

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.