TOTAL BILIRUBIN REAGENT SET— 510(k) K860214

Name: FDA 510(k) clearance K860214
Creator: U.S. Food and Drug Administration
Published: 1986-03-17

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K860214 for TOTAL BILIRUBIN REAGENT SET, Substantially Equivalent on 1986-03-17. Applicant: Sterling Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1986-01-22
Decision date: 1986-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, US

Download summary PDF View on FDA.gov ↗

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