Cleared Special

CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127

K092868 · CellaVision AB · Hematology
Nov 2009
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K092868 is an FDA 510(k) clearance for the CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127, 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 November 20, 2009, 63 days after receiving the submission on September 18, 2009. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K092868 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2009
Decision Date November 20, 2009
Days to Decision 63 days
Submission Type Special
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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