INFINITT DPS— 510(k) K243449

Substantially Equivalent

Infinitt Healthcare Co., Ltd.

FDA 510(k) clearance K243449 for INFINITT DPS, Substantially Equivalent on 2025-12-09. Applicant: Infinitt Healthcare Co., Ltd.. Device class: 2.

Clearance details

Applicant: Infinitt Healthcare Co., Ltd.
Product code: Code QKQ
Device class: Class 2
Regulation: 21 CFR 864.3700
Advisory panel: Pathology
Date received: 2024-11-07
Decision date: 2025-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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