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FDA 510(k) Application Details - K962873
Device Classification Name
More FDA Info for this Device
510(K) Number
K962873
Device Name
CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE
Applicant
VYSIS
3100 WOODCREEK DR.
DOWNERS GROVE, IL 60515 US
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Contact
RUSSEL K ENNS
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OVQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/23/1996
Decision Date
01/13/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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