Cleared Traditional

CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER

K033840 · CellaVision AB · Hematology
Feb 2004
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K033840 is an FDA 510(k) clearance for the CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER, 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 February 10, 2004, 62 days after receiving the submission on December 10, 2003. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K033840 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2003
Decision Date February 10, 2004
Days to Decision 62 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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