InTray GC— 510(k) K210511

Substantially Equivalent

Biomed Diagnostics Incorporated

FDA 510(k) clearance K210511 for InTray GC, Substantially Equivalent on 2021-10-20. Applicant: Biomed Diagnostics Incorporated. Device class: 2.

Clearance details

Applicant: Biomed Diagnostics Incorporated
Product code: Code JTY
Device class: Class 2
Regulation: 21 CFR 866.2410
Advisory panel: Microbiology
Date received: 2021-02-23
Decision date: 2021-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White City, OR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTY

K993033 — INTRAY GC1999-12-16
K954986 — GC BASE W/ 1% GCHI1996-02-16
K950196 — CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA1995-06-30
K933122 — MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR1994-02-09
K933121 — MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR1994-02-03

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