Cleared Traditional

SERIM DISINTEK OPA TEST STRIP

K081370 · Serim Research Corp. · General Hospital
Jul 2008
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K081370 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 July 11, 2008, 57 days after receiving the submission on May 15, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K081370 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2008
Decision Date July 11, 2008
Days to Decision 57 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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