THE MERETEK UBT BREATH TEST FOR H.PYLORI— 510(k) K972352

Name: FDA 510(k) clearance K972352
Creator: U.S. Food and Drug Administration
Published: 1997-10-29

Substantially Equivalent

Meretek Diagnostics, Inc.

FDA 510(k) clearance K972352 for THE MERETEK UBT BREATH TEST FOR H.PYLORI, Substantially Equivalent on 1997-10-29. 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: 1997-06-24
Decision date: 1997-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nashville, TN, US

Download summary PDF View on FDA.gov ↗

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