Cleared Traditional

CELLAVISION DM96 WITH THE BODY FLUID APPLICATION

K080595 · CellaVision AB · Hematology
Dec 2008
Decision
277d
Days
Class 2
Risk

About This 510(k) Submission

K080595 is an FDA 510(k) clearance for the CELLAVISION DM96 WITH THE BODY FLUID APPLICATION, a Device, Automated Cell-locating (Class II — Special Controls, product code JOY), submitted by CellaVision AB (Minneapolis,, US). The FDA issued a Cleared decision on December 5, 2008, 277 days after receiving the submission on March 3, 2008. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K080595 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2008
Decision Date December 05, 2008
Days to Decision 277 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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