Cleared Traditional

CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION

K102778 · CellaVision AB · Hematology
Sep 2011
Decision
357d
Days
Class 2
Risk

About This 510(k) Submission

K102778 is an FDA 510(k) clearance for the CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION, a Device, Automated Cell-locating (Class II — Special Controls, product code JOY), submitted by CellaVision AB (Fridley, US). The FDA issued a Cleared decision on September 16, 2011, 357 days after receiving the submission on September 24, 2010. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K102778 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2010
Decision Date September 16, 2011
Days to Decision 357 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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