Chagas Detect Plus Rapid Test— 510(k) K161947

Name: FDA 510(k) clearance K161947
Creator: U.S. Food and Drug Administration
Published: 2016-12-16

Substantially Equivalent

InBios International, Inc.

FDA 510(k) clearance K161947 for Chagas Detect Plus Rapid Test, Substantially Equivalent on 2016-12-16. Applicant: InBios International, Inc.. Device class: 1.

Clearance details

Applicant: InBios International, Inc.
Product code: Code MIU
Device class: Class 1
Regulation: 21 CFR 866.3870
Advisory panel: Microbiology
Date received: 2016-07-14
Decision date: 2016-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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