Atlas FDA

CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY

FDA 510(k) clearance K110215 · decided 2012-12-17

Clearance details

K-number
K110215
Device name
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
Applicant
Ventana Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
2010-12-29
Decision date
2012-12-17
Days to decision
719 days
Clearance type
Traditional
Product code
MYA
Device class
2
Regulation number
864.1860
Medical specialty
Hematology
Advisory committee
Hematology
Location
Tucson, AZ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
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