VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS— 510(k) K032296

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K032296 for VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS, Substantially Equivalent on 2003-08-13. Applicant: Ortho-Clinical Diagnostics, Inc..

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code JIS
Advisory panel: Clinical Chemistry
Date received: 2003-07-25
Decision date: 2003-08-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

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