BOND MMR Antibody Panel— 510(k) K213348

Name: FDA 510(k) clearance K213348
Creator: U.S. Food and Drug Administration
Published: 2023-02-21

Substantially Equivalent

Leica Biosystems Newcastle, Ltd.

FDA 510(k) clearance K213348 for BOND MMR Antibody Panel, Substantially Equivalent on 2023-02-21. Applicant: Leica Biosystems Newcastle, Ltd.. Device class: 2.

Clearance details

Applicant: Leica Biosystems Newcastle, Ltd.
Product code: Code PZJ
Device class: Class 2
Regulation: 21 CFR 864.1866
Advisory panel: Immunology
Date received: 2021-10-08
Decision date: 2023-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newcastle Upon Tyne, GB

Download summary PDF View on FDA.gov ↗

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