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VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RAN — Ortho-Clinical Diagnostics, Inc. (510

VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RAN — Ortho-Clinical Diagnostics, Inc. (510 is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RAN; Applican

Device nameVITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RAN
ApplicantOrtho-Clinical Diagnostics, Inc.
Clearance track510(k)
Submission numberK990783
DecisionSubstantially Equivalent
Decision date1999-03-25
Date received1999-03-09
Product codeJJX
Device class1
Medical specialtyClinical Chemistry
Applicant locationNY, US
SourceopenFDA device

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