NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928— 510(k) K854717

Name: FDA 510(k) clearance K854717
Creator: U.S. Food and Drug Administration
Published: 1986-01-14

Substantially Equivalent

Nobel Scientific Industries, Inc.

FDA 510(k) clearance K854717 for NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928, Substantially Equivalent on 1986-01-14. Applicant: Nobel Scientific Industries, Inc.. Device class: 2.

Clearance details

Applicant: Nobel Scientific Industries, Inc.
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1985-11-22
Decision date: 1986-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alexandria, VA, US

Download summary PDF View on FDA.gov ↗

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