Atlas FDA

APTIMA TRICHOMONAS VAGINALIS ASSAY

FDA 510(k) clearance DEN110012 · decided 2011-04-19

Clearance details

K-number
DEN110012
Device name
APTIMA TRICHOMONAS VAGINALIS ASSAY
Applicant
Gen-Probe Incorporated
Decision
Unknown
Date received
2011-04-13
Decision date
2011-04-19
Days to decision
6 days
Clearance type
Post-NSE
Product code
OUY
Device class
2
Regulation number
866.3860
Medical specialty
Immunology
Advisory committee
Immunology
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.

PMA approvals by this applicant

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Aptima HPV-GT Assay (P120007/S032)Gen-Probe Incorporated2024-10-23
Aptima HPV Assay (P100042/S037)Gen-Probe Incorporated2024-10-23
Aptima HPV-GT Assay (P120007/S031)Gen-Probe Incorporated2024-07-26
Aptima HPV Assay (P100042/S036)Gen-Probe Incorporated2024-07-26
Aptima HPV Assay (P100042/S035)Gen-Probe Incorporated2023-07-07
Aptima HPV 16 18/45 Genotype Assay (P120007/S030)Gen-Probe Incorporated2023-06-02