Atlas FDA

VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67

FDA 510(k) clearance K053520 · decided 2006-04-11

Clearance details

K-number
K053520
Device name
VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67
Applicant
Tripath Imaging, Inc.
Decision
Substantially Equivalent
Date received
2005-12-19
Decision date
2006-04-11
Days to decision
113 days
Clearance type
Traditional
Product code
NQN
Device class
2
Regulation number
864.1860
Medical specialty
Hematology
Advisory committee
Hematology
Location
Durham, NC, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.