DENV Detect NS1 ELISA— 510(k) K181473

Name: FDA 510(k) clearance K181473
Creator: U.S. Food and Drug Administration
Published: 2018-08-27

Substantially Equivalent

InBios International, Inc.

FDA 510(k) clearance K181473 for DENV Detect NS1 ELISA, Substantially Equivalent on 2018-08-27. Applicant: InBios International, Inc.. Device class: 2.

Clearance details

Applicant: InBios International, Inc.
Product code: Code QCU
Device class: Class 2
Regulation: 21 CFR 866.3945
Advisory panel: Microbiology
Date received: 2018-06-04
Decision date: 2018-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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