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FDA 510(k)

WHITE BLOOD CELLS HUMAN TAND B

K-Number: K833929 · 1984-02-03

ApplicantControl Diagnostics
Decision Date1984-02-03
Product CodeLIZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

WHITE BLOOD CELLS HUMAN TAND B is the device name listed in this FDA 510(k) record. The listed applicant is Control Diagnostics. It received FDA 510(k) clearance on 1984-02-03 under 510(k) number K833929. The device is classified under product code LIZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WHITE BLOOD CELLS HUMAN TAND B?

WHITE BLOOD CELLS HUMAN TAND B is a medical device that received FDA 510(k) clearance on 1984-02-03. The listed applicant is Control Diagnostics. The 510(k) number is K833929.

When did WHITE BLOOD CELLS HUMAN TAND B receive FDA 510(k) clearance?

WHITE BLOOD CELLS HUMAN TAND B received FDA 510(k) clearance on 1984-02-03, under 510(k) number K833929.

Who is the listed applicant for WHITE BLOOD CELLS HUMAN TAND B?

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

What is the FDA product code for WHITE BLOOD CELLS HUMAN TAND B?

The FDA product code for WHITE BLOOD CELLS HUMAN TAND B is LIZ.

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_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Control Diagnostics 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.

K830864WHITE BLOOD CELL CONTROL

Related Devices (Code: LIZ)

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.

K914847CD8 MONOCLONAL ANTIBODIESGen Trak, Inc.K860830TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHODTechnicon Instruments Corp.K843062TBM-REAGENT FOR T,B CELL & MONOCYTESBd Becton Dickinson Vacutainer Systems PreanalyticK842218ANTI-LEU-4 FITC LYSIN C BUFFERBd Becton Dickinson Vacutainer Systems PreanalyticK831053QUANTIGEN T & B CELL ASSAYBio-RadK820643ORTHO SPECTRUM III & ORTHO-MUNE OKOrtho Diagnostic Systems, 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.

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