DENV Detect NS1 ELISA
FDA 510(k) clearance K181473 · decided 2018-08-27
Clearance details
- K-number
- K181473
- Device name
- DENV Detect NS1 ELISA
- Applicant
- InBios International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-06-04
- Decision date
- 2018-08-27
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- QCU
- Device class
- 2
- Regulation number
- 866.3945
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.