Cleared Traditional

CHEMDI-VHP CHEMICAL INDICATOR

K922485 · American Sterilizer Co. · General Hospital
Sep 1993
Decision
499d
Days
Class 2
Risk

About This 510(k) Submission

K922485 is an FDA 510(k) clearance for the CHEMDI-VHP CHEMICAL INDICATOR, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by American Sterilizer Co. (Erie, US). The FDA issued a Cleared decision on September 29, 1993, 499 days after receiving the submission on May 18, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K922485 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 1992
Decision Date September 29, 1993
Days to Decision 499 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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