Atlas FDA

SOFIA ANALYZER AND INFLUENZA A+B FIA

FDA 510(k) clearance K112177 · decided 2011-10-24

Clearance details

K-number
K112177
Device name
SOFIA ANALYZER AND INFLUENZA A+B FIA
Applicant
Quidel Corp.
Decision
Substantially Equivalent
Date received
2011-07-28
Decision date
2011-10-24
Days to decision
88 days
Clearance type
Traditional
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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Recalls involving this device

RecordFirmDate
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic. recall (Z-0819-2013)Quidel Corporation2013-02-14

PMA approvals by this applicant

RecordFirmDate
QUS-2 CALCANEAL ULTRASONOMETER (P990039/S001)Quidel Corp.2003-06-19
QUS-2 (TM) CALCANEAL ULTRASONOMETER (P990039)Quidel Corp.2000-08-01