The following data is part of a premarket notification filed by Inbios International, Inc. with the FDA for Denv Detect Ns1 Elisa.
| Device ID | K181473 |
| 510k Number | K181473 |
| Device Name: | DENV Detect NS1 ELISA |
| Classification | Dengue Virus Antigen Assay |
| Applicant | InBios International, Inc. 307 Westlake Ave N, Suite 300 Seattle, WA 98109 |
| Contact | Estela Raychaudhuri |
| Correspondent | Estela Raychaudhuri InBios International, Inc. 307 Westlake Ave N, Suite 300 Seattle, WA 98109 |
| Product Code | QCU |
| CFR Regulation Number | 866.3945 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-04 |
| Decision Date | 2018-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239060907 | K181473 | 000 |