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ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG — Roche Diagnostics Corp. (510(k) K073501)

ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG — Roche Diagnostics Corp. (510(k) K073501) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG; Applicant: Roche Diagnostics Corp.; Clearan

Device nameROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
ApplicantRoche Diagnostics Corp.
Clearance track510(k)
Submission numberK073501
DecisionSubstantially Equivalent
Decision date2008-06-09
Date received2007-12-13
Product codeLGD
Device class2
Medical specialtyMicrobiology
Applicant locationIN, US
SourceopenFDA device

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