510(k) K181473
- Device
- DENV Detect NS1 ELISA
- Applicant
- InBios International, Inc.
- 510(k) number
- K181473
- Product code
- QCU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-08-27
- Date received
- 2018-06-04
- Regulation
- 866.3945
- Classification name
- Dengue Virus Antigen Assay
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Estela Raychaudhuri
- Address
- 307 Westlake Ave. N, Suite 300 Seattle WA US 98109 98109
FDA Registration Numbers#
- 2032682
- 2029372
- 3002800697
- 3024753119
- 3017013438
- 3032562
- 2245285
- 3011561946
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
Decision Summary