MERETEK UBT_LITE BREATH TEST FOR H. PYLORI— 510(k) K000316

Name: FDA 510(k) clearance K000316
Creator: U.S. Food and Drug Administration
Published: 2000-02-24

Substantially Equivalent

Meretek

FDA 510(k) clearance K000316 for MERETEK UBT_LITE BREATH TEST FOR H. PYLORI, Substantially Equivalent on 2000-02-24. Applicant: Meretek. Device class: 1.

Clearance details

Applicant: Meretek
Product code: Code MSQ
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 2000-02-01
Decision date: 2000-02-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Nashville, TN, US

Download summary PDF View on FDA.gov ↗

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