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ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY — Roche Diagnostics (510(k) K131605)

ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY — Roche Diagnostics (510(k) K131605) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY; Applicant: Roche Diagnostics; Clearance track: 510(k).

Device nameELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
ApplicantRoche Diagnostics
Clearance track510(k)
Submission numberK131605
DecisionSubstantially Equivalent
Decision date2014-02-28
Date received2013-06-03
Product codeLFZ
Device class2
Medical specialtyMicrobiology
Applicant locationIN, US
SourceopenFDA device

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