Atlas FDA

AmpliVue Trichomonas Assay

FDA 510(k) clearance K143329 · decided 2015-03-17

Clearance details

K-number
K143329
Device name
AmpliVue Trichomonas Assay
Applicant
Quidel Corporation
Decision
Substantially Equivalent
Date received
2014-11-20
Decision date
2015-03-17
Days to decision
117 days
Clearance type
Traditional
Product code
OUY
Device class
2
Regulation number
866.3860
Medical specialty
Immunology
Advisory committee
Immunology
Location
Athens, OH, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.