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FDA 510(k)

Viral Transport Medium

K-Number: K233534 · 2024-08-02

Decision Date2024-08-02
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Viral Transport Medium is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K233534. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Viral Transport Medium?

Viral Transport Medium is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Hardy Diagnostics. The 510(k) number is K233534.

When did Viral Transport Medium receive FDA 510(k) clearance?

Viral Transport Medium received FDA 510(k) clearance on 2024-08-02, under 510(k) number K233534.

Who is the listed applicant for Viral Transport Medium?

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 Viral Transport Medium?

The FDA product code for Viral Transport Medium is JSM.

Other records listing Hardy Diagnostics as applicant

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.

View all 22 devices →

Related Devices (Code: JSM)

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.

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.