Atlas FDA

Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)

FDA 510(k) clearance K143653 · decided 2015-09-04

Clearance details

K-number
K143653
Device name
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
Applicant
Nanosphere, Inc.
Decision
Substantially Equivalent
Date received
2014-12-23
Decision date
2015-09-04
Days to decision
255 days
Clearance type
Traditional
Product code
OCC
Device class
2
Regulation number
866.3980
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Northbrook, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system recall (Z-1092-2022)Luminex Corporation2022-05-13