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ABUSCREEN ONLINE BENZ 200 CALIBRATORS — Roche Diagnostic Systems, Inc. (510(k) K983555)

ABUSCREEN ONLINE BENZ 200 CALIBRATORS — Roche Diagnostic Systems, Inc. (510(k) K983555) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ABUSCREEN ONLINE BENZ 200 CALIBRATORS; Applicant: Roche Diagnostic Systems, Inc.; Clearance track: 510(k).

Device nameABUSCREEN ONLINE BENZ 200 CALIBRATORS
ApplicantRoche Diagnostic Systems, Inc.
Clearance track510(k)
Submission numberK983555
DecisionSubstantially Equivalent
Decision date1998-12-15
Date received1998-10-13
Product codeDLJ
Device class2
Medical specialtyClinical Toxicology
Applicant locationNJ, US
SourceopenFDA device

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