K161947 is an FDA 510(k) clearance for the Chagas Detect Plus Rapid Test. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.3870.
| 510(k) Number | K161947 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | MIU - Enzyme Linked Immunosorbent Assay, T. Cruzi |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3870 |