Cleared Traditional

EASYCELL CELL LOCATOR

K092116 · Medica Corp. · Hematology
May 2010
Decision
302d
Days
Class 2
Risk

About This 510(k) Submission

K092116 is an FDA 510(k) clearance for the EASYCELL CELL LOCATOR, a Device, Automated Cell-locating (Class II — Special Controls, product code JOY), submitted by Medica Corp. (Beverly, US). The FDA issued a Cleared decision on May 12, 2010, 302 days after receiving the submission on July 14, 2009. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K092116 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2009
Decision Date May 12, 2010
Days to Decision 302 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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