FDA 510(k)

MRCP+ v1.0

K-Number: K183133 · 2019-01-09

Decision Date2019-01-09

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MRCP+ v1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Perspectum Diagnostics, Ltd.. It received FDA 510(k) clearance on 2019-01-09 under 510(k) 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. The listed applicant is Perspectum Diagnostics, Ltd.. The 510(k) number is K183133.

When did MRCP+ v1.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for MRCP+ v1.0?

The FDA 510(k) record lists Perspectum Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Perspectum Diagnostics, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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