510(k) K181473
K181473 is an FDA 510(k) premarket notification submitted by InBios International, Inc. for the device "DENV Detect NS1 ELISA". The FDA issued a decision of Substantially Equivalent on August 27, 2018. The device falls under product code QCU (Dengue Virus Antigen Assay), a Class II device regulated under 21 CFR 866.3945. InBios International, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2018
- Date Received
- June 4, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dengue Virus Antigen Assay
- Device Class
- Class II
- Regulation Number
- 866.3945
- Review Panel
- MI
- Submission Type
Qualitative detection of Dengue virus antigen in human serum or plasma collected from human patients with signs and symptoms consistent with Dengue virus infection