Cleared Traditional

Chagas Detect Plus Rapid Test

K161947 · InBios International, Inc. · Microbiology
Dec 2016
Decision
155d
Days
Class 1
Risk

About This 510(k) Submission

K161947 is an FDA 510(k) clearance for the Chagas Detect Plus Rapid Test, a Enzyme Linked Immunosorbent Assay, T. Cruzi (Class I — General Controls, product code MIU), submitted by InBios International, Inc. (Seattle, US). The FDA issued a Cleared decision on December 16, 2016, 155 days after receiving the submission on July 14, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3870.

Submission Details

510(k) Number K161947 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2016
Decision Date December 16, 2016
Days to Decision 155 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code MIU — Enzyme Linked Immunosorbent Assay, T. Cruzi
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3870

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