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 |