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Device Classification Name
system, automated scanning microscope and image analysis for fluorescence in situ hybridization (fish) assays
510(k) Number
K042542
Device Name
CYTOVISION FOR CEP XY
Applicant
APPLIED IMAGING CORP.
120 BAYTECH DRIVE
SAN JOSE, CA 95134 -2302
Applicant Contact
DIANE C DAY
Correspondent
APPLIED IMAGING CORP.
120 BAYTECH DRIVE
SAN JOSE, CA 95134 -2302
Correspondent Contact
DIANE C DAY
Regulation Number
866.4700
Classification Product Code
NTH
Date Received
09/20/2004
Decision Date
01/10/2005
Decision
Substantially Equivalent (SESE)
Regulation Medical Specialty
Immunology
510k Review Panel
Hematology
Statement
Statement
FDA Review
Decision Summary
Type
Traditional
Reviewed by Third Party
No
Combination Product
No
Recalls
CDRH Recalls
-
-