EZ-HBT HELICOBACTER BLOOD TEST— 510(k) K990931

Name: FDA 510(k) clearance K990931
Creator: U.S. Food and Drug Administration
Published: 1999-09-24

Substantially Equivalent

Metabolic Solutions, Inc.

FDA 510(k) clearance K990931 for EZ-HBT HELICOBACTER BLOOD TEST, Substantially Equivalent on 1999-09-24. Applicant: Metabolic Solutions, Inc.. Device class: 1.

Clearance details

Applicant: Metabolic Solutions, Inc.
Product code: Code MSQ
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 1999-03-19
Decision date: 1999-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nashua, NH, US

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