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FDA 510(k) Application Details - K150588
Device Classification Name
Ovarian Adnexal Mass Assessment Score Test System
More FDA Info for this Device
510(K) Number
K150588
Device Name
Ovarian Adnexal Mass Assessment Score Test System
Applicant
VERMILLION, INC.
12117 BEE CAVES RD., BLDG III, SUITE 100
AUSTIN, TX 78738 US
Other 510(k) Applications for this Company
Contact
Benjamin A Kimball
Other 510(k) Applications for this Contact
Regulation Number
866.6050
More FDA Info for this Regulation Number
Classification Product Code
ONX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/09/2015
Decision Date
03/18/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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