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FDA 510(k)

InTray GC

K-Number: K210511 · 2021-10-20

ApplicantBiomed Diagnostics Incorporated
Decision Date2021-10-20
Product CodeJTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

InTray GC is the device name listed in this FDA 510(k) record. The listed applicant is Biomed Diagnostics Incorporated. It received FDA 510(k) clearance on 2021-10-20 under 510(k) 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. The listed applicant is Biomed Diagnostics Incorporated. The 510(k) number is K210511.

When did InTray GC receive FDA 510(k) clearance?

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

Who is the listed applicant for InTray GC?

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

What is the FDA product code for InTray GC?

The FDA product code for InTray GC is JTY.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Related Devices (Code: JTY)

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.

K993033INTRAY GCBiomed Diagnostics, Inc.K954986GC BASE W/ 1% GCHIRemel, L.P.K950196CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIABioclinical Systems, Inc.K933122MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGARBioclinical Systems, Inc.K933121MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGARBioclinical Systems, Inc.K934331THAYER MARTIN, MODIFIED PILL POCKETHardy 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.

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