510(k) K161947
K161947 is an FDA 510(k) premarket notification submitted by InBios International, Inc. for the device "Chagas Detect Plus Rapid Test". The FDA issued a decision of Substantially Equivalent on December 16, 2016. The device falls under product code MIU (Enzyme Linked Immunosorbent Assay, T. Cruzi), a Class I device regulated under 21 CFR 866.3870. InBios International, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2016
- Date Received
- July 14, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Linked Immunosorbent Assay, T. Cruzi
- Device Class
- Class I
- Regulation Number
- 866.3870
- Review Panel
- MI
- Submission Type