Cleared Traditional

SCANVIEW, MODEL SC-300

K071398 · Applied Spectral Imaging , Ltd. · Hematology
Oct 2007
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K071398 is an FDA 510(k) clearance for the SCANVIEW, MODEL SC-300, a Device, Automated Cell-locating (Class II — Special Controls, product code JOY), submitted by Applied Spectral Imaging , Ltd. (Ramat Gavriel Migdal Hahemek, IL). The FDA issued a Cleared decision on October 4, 2007, 136 days after receiving the submission on May 21, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K071398 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 2007
Decision Date October 04, 2007
Days to Decision 136 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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