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FDA 510(k)

MRCP+ v1.0

K-Number: K183133 · 2019-01-09

ApplicantPerspectum Diagnostics, Ltd.
Decision Date2019-01-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRCP+ v1.0 is a medical device manufactured by Perspectum Diagnostics, Ltd.. It received FDA 510(k) clearance on 2019-01-09 under approval number K183133. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRCP+ v1.0?

MRCP+ v1.0 is a medical device that received FDA 510(k) clearance on 2019-01-09. It is manufactured by Perspectum Diagnostics, Ltd.. The 510(k) number is K183133.

When was MRCP+ v1.0 approved by the FDA?

MRCP+ v1.0 received FDA 510(k) clearance on 2019-01-09, under approval number K183133.

What company makes MRCP+ v1.0?

MRCP+ v1.0 is manufactured by Perspectum Diagnostics, Ltd..

What is the FDA product code for MRCP+ v1.0?

The FDA product code for MRCP+ v1.0 is LLZ.

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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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