Cleared Traditional

WINSCAN AUTOMATED IMAGING SYSTEM

K980375 · Applied Imaging Corp. · Hematology
Jun 1998
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K980375 is an FDA 510(k) clearance for the WINSCAN AUTOMATED IMAGING SYSTEM, a Device, Automated Cell-locating (Class II — Special Controls, product code JOY), submitted by Applied Imaging Corp. (Santa Clara, US). The FDA issued a Cleared decision on June 9, 1998, 130 days after receiving the submission on January 30, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K980375 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 1998
Decision Date June 09, 1998
Days to Decision 130 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JOY — Device, Automated Cell-locating
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5260

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