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FDA PMA

System, test, tumor marker, for detection of bladder cancer

PMA Number: P940035 · 2022-07-12

ApplicantAbbott Diagnostics Scarborough, Inc.
Decision Date2022-07-12
PMA NumberP940035
Product CodeNAH
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeIM

Device Summary

System, test, tumor marker, for detection of bladder cancer is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics Scarborough, Inc.. It received FDA 510(k) clearance on 2022-07-12. The device is classified under product code NAH. It was reviewed by the IM advisory panel.

Frequently Asked Questions

What is the System, test, tumor marker, for detection of bladder cancer?

System, test, tumor marker, for detection of bladder cancer is a medical device that received FDA 510(k) clearance on 2022-07-12. The listed applicant is Abbott Diagnostics Scarborough, Inc..

When did System, test, tumor marker, for detection of bladder cancer receive FDA 510(k) clearance?

The clearance date for System, test, tumor marker, for detection of bladder cancer can be found in the official FDA records.

Who is the listed applicant for System, test, tumor marker, for detection of bladder cancer?

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

What is the FDA product code for System, test, tumor marker, for detection of bladder cancer?

The FDA product code for System, test, tumor marker, for detection of bladder cancer is NAH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

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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