Atlas FDA

PROFLU+ ASSAY

FDA 510(k) clearance K110968 · decided 2011-06-27

Clearance details

K-number
K110968
Device name
PROFLU+ ASSAY
Applicant
Gen-Probe Prodesse, Inc.
Decision
Substantially Equivalent
Date received
2011-04-06
Decision date
2011-06-27
Days to decision
82 days
Clearance type
Traditional
Product code
OCC
Device class
2
Regulation number
866.3980
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Waukesha, WI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.