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FDA 510(k)

Advanced RBC Application

K-Number: K171315 · 2017-08-01

ApplicantCellaVision AB
Decision Date2017-08-01
Product CodeJOY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Advanced RBC Application is a medical device manufactured by CellaVision AB. It received FDA 510(k) clearance on 2017-08-01 under approval number K171315. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Advanced RBC Application?

Advanced RBC Application is a medical device that received FDA 510(k) clearance on 2017-08-01. It is manufactured by CellaVision AB. The 510(k) number is K171315.

When was Advanced RBC Application approved by the FDA?

Advanced RBC Application received FDA 510(k) clearance on 2017-08-01, under approval number K171315.

What company makes Advanced RBC Application?

Advanced RBC Application is manufactured by CellaVision AB.

What is the FDA product code for Advanced RBC Application?

The FDA product code for Advanced RBC Application is JOY.

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Other Devices by CellaVision AB

K200595CellaVision DC-1, CellaVision DC-1 PPA

Related Devices (Code: JOY)

K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceSysmex America, Inc. K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision AB K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd. K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd. K221309AI100 with ShonitSigtuple Technologies Pvt. , Ltd. K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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