Atlas FDA

ProFlu+ Assay

FDA 510(k) clearance K153219 · decided 2015-11-20

Clearance details

K-number
K153219
Device name
ProFlu+ Assay
Applicant
Hologic, Inc.
Decision
Substantially Equivalent
Date received
2015-11-05
Decision date
2015-11-20
Days to decision
15 days
Clearance type
Special
Product code
OCC
Device class
2
Regulation number
866.3980
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

No recalls on record reference this clearance.

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