Cleared Traditional

SERIM DISINTEK OPA TEST STRIP

K082352 · Serim Research Corp. · General Hospital
Sep 2008
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K082352 is an FDA 510(k) clearance for the SERIM DISINTEK OPA TEST STRIP, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on September 25, 2008, 40 days after receiving the submission on August 16, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K082352 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2008
Decision Date September 25, 2008
Days to Decision 40 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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