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FDA 510(k)

Strep B Carrot Broth Kit

K-Number: K170481 · 2017-05-16

ApplicantHardy Diagnostics
Decision Date2017-05-16
Product CodePQZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Strep B Carrot Broth Kit is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 2017-05-16 under 510(k) 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. The listed applicant is Hardy Diagnostics. The 510(k) number is K170481.

When did Strep B Carrot Broth Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Strep B Carrot Broth Kit?

The FDA 510(k) record lists Hardy Diagnostics as the applicant. This does not by itself establish the device manufacturer.

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 records listing Hardy Diagnostics as applicant

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Related Devices (Code: PQZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173903Granada MediumHardy DiagnosticsK170586Strep B Carrot Broth One-StepHardy DiagnosticsK163042chromID Strepto B agarbioMerieux, Inc.

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.

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