FDA 510(k)

MeMed BV

K-Number: K210254 · 2021-09-01

Decision Date2021-09-01

Product CodeQPS

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

MeMed BV is the device name listed in this FDA 510(k) record. The listed applicant is MeMed Diagnostics, Ltd.. It received FDA 510(k) clearance on 2021-09-01 under 510(k) number K210254. The device is classified under product code QPS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MeMed BV?

MeMed BV is a medical device that received FDA 510(k) clearance on 2021-09-01. The listed applicant is MeMed Diagnostics, Ltd.. The 510(k) number is K210254.

When did MeMed BV receive FDA 510(k) clearance?

MeMed BV received FDA 510(k) clearance on 2021-09-01, under 510(k) number K210254.

Who is the listed applicant for MeMed BV?

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

What is the FDA product code for MeMed BV?

The FDA product code for MeMed BV is QPS.

Other records listing MeMed 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.

K230944MeMed BV K222332MeMed BV

Related Devices (Code: QPS)

K230944MeMed BVMeMed Diagnostics, Ltd.K222332MeMed BVMeMed Diagnostics, Ltd.K213936LIAISON MeMed BV, LIAISON MeMed BV Control SetDiaSorin, Inc.

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.