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FDA 510(k)

BOND MMR Antibody Panel

K-Number: K213348 · 2023-02-21

ApplicantLeica Biosystems Newcastle, Ltd.
Decision Date2023-02-21
Product CodePZJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BOND MMR Antibody Panel is a medical device manufactured by Leica Biosystems Newcastle, Ltd.. It received FDA 510(k) clearance on 2023-02-21 under approval number K213348. The device is classified under product code PZJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOND MMR Antibody Panel?

BOND MMR Antibody Panel is a medical device that received FDA 510(k) clearance on 2023-02-21. It is manufactured by Leica Biosystems Newcastle, Ltd.. The 510(k) number is K213348.

When was BOND MMR Antibody Panel approved by the FDA?

BOND MMR Antibody Panel received FDA 510(k) clearance on 2023-02-21, under approval number K213348.

What company makes BOND MMR Antibody Panel?

BOND MMR Antibody Panel is manufactured by Leica Biosystems Newcastle, Ltd..

What is the FDA product code for BOND MMR Antibody Panel?

The FDA product code for BOND MMR Antibody Panel is PZJ.

Other Devices by Leica Biosystems Newcastle, Ltd.

K193393BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).

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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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