InBios International, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
InBios International, Inc. - FDA 510(k) Cleared Devices
Recent clearances: COVID-19 Detect Rapid Self -Test, SCoV-2 Ag Detect Rapid Test, DENV Detect NS1 ELISA
7
Total
5
Cleared
2
Denied
InBios International, Inc. has 5 FDA 510(k) cleared medical devices. Based in Seattle, US.
Latest FDA clearance: Oct 2025. Active since 2014. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by InBios International, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - InBios International, Inc.
7 devices
Cleared
Oct 12, 2025
COVID-19 Detect Rapid Self -Test
Microbiology
138d
Cleared
Aug 23, 2024
SCoV-2 Ag Detect Rapid Test
Microbiology
329d
Not Cleared
Feb 03, 2023
Active Anthrax DetectTM Plus Rapid Test
Microbiology
210d
Not Cleared
May 23, 2019
ZIKV Detect 2.0 IgM Capture ELISA
Microbiology
148d
Cleared
Aug 27, 2018
DENV Detect NS1 ELISA
Microbiology
84d
Cleared
Dec 16, 2016
Chagas Detect Plus Rapid Test
Microbiology
155d
Cleared
Nov 14, 2014
CL DETECT RAPID TEST
Microbiology
177d