Green Card Bowie-Dick Test (BD115)— 510(k) K250172

Name: FDA 510(k) clearance K250172
Creator: U.S. Food and Drug Administration
Published: 2025-02-20

Substantially Equivalent

Steritec Products, Inc. (A Getinge Company)

FDA 510(k) clearance K250172 for Green Card Bowie-Dick Test (BD115), Substantially Equivalent on 2025-02-20. Applicant: Steritec Products, Inc. (A Getinge Company). Device class: 2.

Clearance details

Applicant: Steritec Products, Inc. (A Getinge Company)
Product code: Code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2025-01-21
Decision date: 2025-02-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Engelwood, CO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.