TOTAL PROTEIN (BIURET) REAGENT SET— 510(k) K860341

Name: FDA 510(k) clearance K860341
Creator: U.S. Food and Drug Administration
Published: 1986-02-11

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K860341 for TOTAL PROTEIN (BIURET) REAGENT SET, Substantially Equivalent on 1986-02-11. Applicant: Sterling Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1986-01-29
Decision date: 1986-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, US

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