Source document or public record

FDA 510(k) K210511 — InTray GC

FDA 510(k) index record K210511. Device: InTray GC. Applicant as listed: Biomed Diagnostics Incorporated. Decision date: 2021-10-20.

OtherU.S. Food and Drug Administration (FDA)2021-10-20

Source

"device_name": "InTray GC"

This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-20

Disclaimer

professional use

FDA 510(k) public index record K210511.

Device name: InTray GC. Applicant as listed: Biomed Diagnostics Incorporated.

Decision date: 2021-10-20. Decision wording: Substantially Equivalent.

Product code: JTY. Regulation: 21 CFR 866.2410. Medical specialty: Microbiology.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

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