VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)— 510(k) K973331

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K973331 for VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340), Substantially Equivalent on 1997-10-22. Applicant: Ortho-Clinical Diagnostics, Inc..

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code DBF
Advisory panel: Immunology
Date received: 1997-09-04
Decision date: 1997-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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