K062077

Substantially Equivalent

VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS

Applicant
Ortho-Clinical Diagnostics, Inc.
Product code
DKZ
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rochester, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.