Atlas FDA

XPECT FLU A & B

FDA 510(k) clearance K092423 · decided 2009-08-26

Clearance details

K-number
K092423
Device name
XPECT FLU A & B
Applicant
Thermo Fisher Scientific
Decision
Substantially Equivalent
Date received
2009-08-07
Decision date
2009-08-26
Days to decision
19 days
Clearance type
Special
Product code
PSZ
Device class
2
Regulation number
866.3328
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Lenexa, KS, US
Third-party review
No
Expedited review
No

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Osom Ultra Plus Flu A&B Test Kit (K192719)SEKISUI Diagnostics, LLC2020-04-03
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

Recalls involving this device

No recalls on record reference this clearance.