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FDA 510(k)

ALPHA DX SYSTEM

K-Number: K010562 · 2001-03-13

ApplicantFirst Medical, Inc.
Decision Date2001-03-13
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALPHA DX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is First Medical, Inc.. It received FDA 510(k) clearance on 2001-03-13 under 510(k) number K010562. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA DX SYSTEM?

ALPHA DX SYSTEM is a medical device that received FDA 510(k) clearance on 2001-03-13. The listed applicant is First Medical, Inc.. The 510(k) number is K010562.

When did ALPHA DX SYSTEM receive FDA 510(k) clearance?

ALPHA DX SYSTEM received FDA 510(k) clearance on 2001-03-13, under 510(k) number K010562.

Who is the listed applicant for ALPHA DX SYSTEM?

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

What is the FDA product code for ALPHA DX SYSTEM?

The FDA product code for ALPHA DX SYSTEM is MMI.

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 First Medical, Inc. 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.

K014024MODIFICATION TO ALPHA DX SYSTEMK013118MODIFICATION TO ALPHA DX SYSTEMK974839ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT

Related Devices (Code: MMI)

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.

K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc.K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.K243483Access hsTnIBeckman Coulter, Inc.K242870Access hsTnIBeckman Coulter, Inc.K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K241165Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, Inc.

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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