Atlas FDA

PRODESSE PROFLU+ ASSAY

FDA 510(k) clearance K132129 · decided 2013-08-09

Clearance details

K-number
K132129
Device name
PRODESSE PROFLU+ ASSAY
Applicant
Gen-Probe Prodesse, Inc.
Decision
Substantially Equivalent
Date received
2013-07-10
Decision date
2013-08-09
Days to decision
30 days
Clearance type
Special
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.