Cleared Traditional

Advanced RBC Application

K171315 · CellaVision AB · Hematology
Aug 2017
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K171315 is an FDA 510(k) clearance for the Advanced RBC Application, 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 August 1, 2017, 89 days after receiving the submission on May 4, 2017. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K171315 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2017
Decision Date August 01, 2017
Days to Decision 89 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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