BREATHTEK - UBIT UBT FOR H. PYLORI— 510(k) K014225

Name: FDA 510(k) clearance K014225
Creator: U.S. Food and Drug Administration
Published: 2002-01-17

Substantially Equivalent

Meretek Diagnostics, Inc.

FDA 510(k) clearance K014225 for BREATHTEK - UBIT UBT FOR H. PYLORI, Substantially Equivalent on 2002-01-17. Applicant: Meretek Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Meretek Diagnostics, Inc.
Product code: Code MSQ
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 2001-12-26
Decision date: 2002-01-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Nashville, TN, US

Download summary PDF View on FDA.gov ↗

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