HEMOGLOBIN REAGENT SET— 510(k) K841057

Name: FDA 510(k) clearance K841057
Creator: U.S. Food and Drug Administration
Published: 1984-03-23

Substantially Equivalent

Medical Specialties, Inc.

FDA 510(k) clearance K841057 for HEMOGLOBIN REAGENT SET, Substantially Equivalent on 1984-03-23. Applicant: Medical Specialties, Inc.. Device class: 2.

Clearance details

Applicant: Medical Specialties, Inc.
Product code: Code GKR
Device class: Class 2
Regulation: 21 CFR 864.5620
Advisory panel: Hematology
Date received: 1984-03-12
Decision date: 1984-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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