The following data is part of a premarket notification filed by Inbios International, Inc. with the FDA for Chagas Detect Plus Rapid Test.
| Device ID | K161947 |
| 510k Number | K161947 |
| Device Name: | Chagas Detect Plus Rapid Test |
| Classification | Enzyme Linked Immunosorbent Assay, T. Cruzi |
| Applicant | INBIOS INTERNATIONAL, INC. 562 1ST AVE. S. SUITE 600 Seattle, WA 98104 |
| Contact | Estela Raychaudhuri |
| Correspondent | Estela Raychaudhuri INBIOS INTERNATIONAL, INC. 562 1ST AVE. S. SUITE 600 Seattle, WA 98104 |
| Product Code | MIU |
| CFR Regulation Number | 866.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-14 |
| Decision Date | 2016-12-16 |