Cleared Traditional

CellaVision DC-1, CellaVision DC-1 PPA

K200595 · CellaVision AB · Hematology
Oct 2020
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K200595 is an FDA 510(k) clearance for the CellaVision DC-1, CellaVision DC-1 PPA, a Device, Automated Cell-locating (Class II — Special Controls, product code JOY), submitted by CellaVision AB (Lund, SE). The FDA issued a Cleared decision on October 16, 2020, 224 days after receiving the submission on March 6, 2020. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K200595 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2020
Decision Date October 16, 2020
Days to Decision 224 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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