Atlas FDA

Osom Ultra Plus Flu A&B Test Kit

FDA 510(k) clearance K192719 · decided 2020-04-03

Clearance details

K-number
K192719
Device name
Osom Ultra Plus Flu A&B Test Kit
Applicant
SEKISUI Diagnostics, LLC
Decision
Substantially Equivalent
Date received
2019-09-26
Decision date
2020-04-03
Days to decision
190 days
Clearance type
Dual Track
Product code
PSZ
Device class
2
Regulation number
866.3328
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
San Diego, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Nano-Check Influenza A+B Test (K252283)Nano-Ditech Corporation2026-01-15
Innovita Flu A/B Antigen Rapid Test (K250398)Innovita (Tangshan) Biological Technology Co., Ltd.2025-07-03
Acucy® Influenza A&B Test with the Acucy® 2 System (K241188)SEKISUI Diagnostics, LLC2025-04-18
BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit (K232434)Bd2023-12-05
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (K223016)Bd2023-01-27
CareStart Flu A&B Plus (K191514)Access Bio, Inc.2020-02-18
Acucy Influenza A&B Test with the Acucy System (K182001)SEKISUI Diagnostics, LLC2018-12-17
BioSign Flu A+B (K182157)Princeton BioMeditech Corp.2018-09-18
Alere BinaxNOW Influenza A & B Card 2, Alere Reader (K181853)Alere Scarborough, Inc.2018-08-08
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (K180438)Bd2018-03-20
QuickVue Influenza A+B (K180288)Quidel Corporation2018-02-13
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit (K173502)Alere Scarborough, Inc.2017-12-13

Recalls involving this device

No recalls on record reference this clearance.