STERRAD Chemical Indicator (CI) Strip (14100) +5 more— 510(k) K234084

Name: FDA 510(k) clearance K234084
Creator: U.S. Food and Drug Administration
Published: 2024-07-05

Substantially Equivalent

Advanced Sterilization Products, Inc.

FDA 510(k) clearance K234084 for STERRAD Chemical Indicator (CI) Strip (14100) +5 more, Substantially Equivalent on 2024-07-05. Applicant: Advanced Sterilization Products, Inc.. Device class: 2.

Clearance details

Device name as filed: STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY Reader (43220); ULTRA GI Process Challenge Device (PCD) (43400)(30 count)
Applicant: Advanced Sterilization Products, Inc.
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2023-12-22
Decision date: 2024-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvin, CA, US

Download summary PDF View on FDA.gov ↗

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