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THE CARDIAC READER SYSTEM — Roche Diagnostics Corp. (510(k) K000784)

THE CARDIAC READER SYSTEM — Roche Diagnostics Corp. (510(k) K000784) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: THE CARDIAC READER SYSTEM; Applicant: Roche Diagnostics Corp.; Clearance track: 510(k).

Device nameTHE CARDIAC READER SYSTEM
ApplicantRoche Diagnostics Corp.
Clearance track510(k)
Submission numberK000784
DecisionSubstantially Equivalent
Decision date2000-05-18
Date received2000-03-10
Product codeMMI
Device class2
Medical specialtyClinical Chemistry
Applicant locationNY, US
SourceopenFDA device

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