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FDA 510(k) Application Details - K941505
Device Classification Name
Lambda, Antigen, Antiserum, Control
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510(K) Number
K941505
Device Name
Lambda, Antigen, Antiserum, Control
Applicant
VENTANA MEDICAL SYSTEMS, INC.
3865 N. BUSINESS CENTER DR.
TUCSON, AZ 85705 US
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Contact
STEPHEN A TILLSON
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Regulation Number
866.5550
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Classification Product Code
DEH
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Date Received
03/29/1994
Decision Date
05/30/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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