HEMOGLOBIN REAGENT SET— 510(k) K860475

Name: FDA 510(k) clearance K860475
Creator: U.S. Food and Drug Administration
Published: 1986-03-03

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K860475 for HEMOGLOBIN REAGENT SET, Substantially Equivalent on 1986-03-03. Applicant: Sterling Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1986-02-07
Decision date: 1986-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, US

Download summary PDF View on FDA.gov ↗

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