VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK— 510(k) K984289

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K984289 for VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, Substantially Equivalent on 1999-03-12. Applicant: Ortho-Clinical Diagnostics, Inc..

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code LTJ
Advisory panel: Immunology
Date received: 1998-12-01
Decision date: 1999-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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