ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR— 510(k) K923739

Name: FDA 510(k) clearance K923739
Creator: U.S. Food and Drug Administration
Published: 1994-12-22

Substantially Equivalent

Abtox, Inc.

FDA 510(k) clearance K923739 for ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR, Substantially Equivalent on 1994-12-22. Applicant: Abtox, Inc.. Device class: 2.

Clearance details

Applicant: Abtox, Inc.
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 1992-07-27
Decision date: 1994-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, IL, US

Download summary PDF View on FDA.gov ↗

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