Atlas FDA

LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER

FDA 510(k) clearance K111387 · decided 2011-08-04

Clearance details

K-number
K111387
Device name
LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER
Applicant
Iquum, Inc.
Decision
Substantially Equivalent
Date received
2011-05-17
Decision date
2011-08-04
Days to decision
79 days
Clearance type
Traditional
Product code
OCC
Device class
2
Regulation number
866.3980
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Marlborough, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay. recall (Z-2203-2016)Roche Molecular Systems, Inc.2016-07-13
cobas Liat Analyzer, for in vitro diagnostic use. recall (Z-2543-2015)Roche Molecular Systems, Inc.2015-09-02