VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS— 510(k) K983674

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K983674 for VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS, Substantially Equivalent on 1999-01-29. Applicant: Ortho-Clinical Diagnostics, Inc..

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code JMM
Advisory panel: Clinical Chemistry
Date received: 1998-10-20
Decision date: 1999-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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