WINSCAN AUTOMATED IMAGING SYSTEM

Device, Automated Cell-locating

APPLIED IMAGING CORP.

The following data is part of a premarket notification filed by Applied Imaging Corp. with the FDA for Winscan Automated Imaging System.

Pre-market Notification Details

Device IDK980375
510k NumberK980375
Device Name:WINSCAN AUTOMATED IMAGING SYSTEM
ClassificationDevice, Automated Cell-locating
Applicant APPLIED IMAGING CORP. 2380 WALSH AVE., BLDG.B Santa Clara,  CA  95051
ContactPatricia A Milbank
CorrespondentPatricia A Milbank
APPLIED IMAGING CORP. 2380 WALSH AVE., BLDG.B Santa Clara,  CA  95051
Product CodeJOY  
CFR Regulation Number864.5260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-30
Decision Date1998-06-09
Summary:summary

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