FDA 510(k)

Chagas Detect Plus Rapid Test

K-Number: K161947 · 2016-12-16

Decision Date2016-12-16

Product CodeMIU

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Chagas Detect Plus Rapid Test is the device name listed in this FDA 510(k) record. The listed applicant is InBios International, Inc.. It received FDA 510(k) clearance on 2016-12-16 under 510(k) number K161947. The device is classified under product code MIU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Chagas Detect Plus Rapid Test?

Chagas Detect Plus Rapid Test is a medical device that received FDA 510(k) clearance on 2016-12-16. The listed applicant is InBios International, Inc.. The 510(k) number is K161947.

When did Chagas Detect Plus Rapid Test receive FDA 510(k) clearance?

Chagas Detect Plus Rapid Test received FDA 510(k) clearance on 2016-12-16, under 510(k) number K161947.

Who is the listed applicant for Chagas Detect Plus Rapid Test?

The FDA 510(k) record lists InBios International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Chagas Detect Plus Rapid Test?

The FDA product code for Chagas Detect Plus Rapid Test is MIU.

Other records listing InBios International, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251595COVID-19 Detect Rapid Self -Test K233358SCoV-2 Ag Detect Rapid Test K181473DENV Detect NS1 ELISA

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.