Inbios International, Inc.
Seattle, WA, US
INBIOS INTERNATIONAL, INC. appears in FDA device records in Seattle, WA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Inbios International, Inc. between 2014 and 2025. The busiest year on record is 2014, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251595 | COVID-19 Detect Rapid Self -Test | QYT | Substantially Equivalent | |
| K233358 | SCoV-2 Ag Detect Rapid Test | QVF | Substantially Equivalent | |
| DEN220044 | Active Anthrax DetectTM Plus Rapid Test | QUU | Unknown | |
| DEN180069 | ZIKV Detect 2.0 IgM Capture ELISA | QFO | Unknown | |
| K181473 | DENV Detect NS1 ELISA | QCU | Substantially Equivalent | |
| K161947 | Chagas Detect Plus Rapid Test | MIU | Substantially Equivalent | |
| K141341 | CL DETECT RAPID TEST | PIT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3032562 | 3002606748 | INBIOS INTERNATIONAL, INC. | 307 Westlake Ave North, Suite 300, Seattle, WA 98109 US | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QKPCoronavirus Antigen Detection Test System.
- OSUDengue Serological Reagents
- QCUDengue Virus Antigen Assay
- NOPElisa, Antibody, West Nile Virus
- MDTElisa, Trichinella Spiralis
- MIUEnzyme Linked Immunosorbent Assay, T. Cruzi
- PITLeishmania Spp. Antigen Detection Assay
- QYTOver-The-Counter Covid-19 Antigen Test
- QKOReagent, Coronavirus Serological
- LOOReagent, Leishmanii Serological
- LSQReagent, Rickettsia Serological
- QJRReagents, 2019-Novel Coronavirus Nucleic Acid
- MVUReagents, Specific, Analyte
- QUUSimple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples
- QVFSimple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
- QFOZika Virus Serological Reagents
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain