Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Leica Biosystems Newcastle, Ltd.. It received FDA 510(k) clearance on 2023-02-21 under 510(k) 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. The listed applicant is Leica Biosystems Newcastle, Ltd.. The 510(k) number is K213348.

When did BOND MMR Antibody Panel receive FDA 510(k) clearance?

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

Who is the listed applicant for BOND MMR Antibody Panel?

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

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

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

Other records listing Leica Biosystems Newcastle, 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.

K193393BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).K183102BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal AntibodyK183100Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, NovocastraK171753BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16

Related Devices (Code: PZJ)

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.

K211181Idylla MSI TestBiocartis NVK200129OncoMate MSI Dx Analysis SystemPromega Corporation

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.

↑