Cleared Traditional

SLIDESCAN

K001420 · Applied Imaging Corp. · Hematology
Aug 2000
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K001420 is an FDA 510(k) clearance for the SLIDESCAN, 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 August 30, 2000, 117 days after receiving the submission on May 5, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K001420 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2000
Decision Date August 30, 2000
Days to Decision 117 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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