Cleared Traditional

DISINTEK? PA Test Strips

K251035 · Serim Research · General Hospital
Jun 2025
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K251035 is an FDA 510(k) clearance for the DISINTEK? PA Test Strips, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by Serim Research (Elkhart, US). The FDA issued a Cleared decision on June 3, 2025, 61 days after receiving the submission on April 3, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K251035 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2025
Decision Date June 03, 2025
Days to Decision 61 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code JOJ — Indicator, Physical/chemical Sterilization Process
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2800

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