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 |