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510(k) K940243

VENTANA EMA PRIMARY ANDIBODY by Ventana Medical Systems, Inc. — Product Code DHF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1994
Date Received
January 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
D/Km-1, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5065
Review Panel
PA
Submission Type

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