HEMOGLOBIN REAGENT— 510(k) K831618

Substantially Equivalent

Omega Medical Diagnostics

FDA 510(k) clearance K831618 for HEMOGLOBIN REAGENT, Substantially Equivalent on 1983-06-16. Applicant: Omega Medical Diagnostics.

Clearance details

Applicant: Omega Medical Diagnostics
Product code: Code GKR
Advisory panel: Hematology
Date received: 1983-05-19
Decision date: 1983-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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