Cleared Traditional

DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER

K003301 · CellaVision AB · Hematology
Mar 2001
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K003301 is an FDA 510(k) clearance for the DIFFMASTER OCTAVIA 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 March 15, 2001, 146 days after receiving the submission on October 20, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K003301 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 2000
Decision Date March 15, 2001
Days to Decision 146 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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