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FDA 510(k)

InTray GC

K-Number: K210511 · 2021-10-20

Decision Date2021-10-20
Product CodeJTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

InTray GC is a medical device manufactured by Biomed Diagnostics Incorporated. It received FDA 510(k) clearance on 2021-10-20 under approval number K210511. The device is classified under product code JTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InTray GC?

InTray GC is a medical device that received FDA 510(k) clearance on 2021-10-20. It is manufactured by Biomed Diagnostics Incorporated. The 510(k) number is K210511.

When was InTray GC approved by the FDA?

InTray GC received FDA 510(k) clearance on 2021-10-20, under approval number K210511.

What company makes InTray GC?

InTray GC is manufactured by Biomed Diagnostics Incorporated.

What is the FDA product code for InTray GC?

The FDA product code for InTray GC is JTY.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.