TOTAL PROTEIN REAGENT SET— 510(k) K843701

Name: FDA 510(k) clearance K843701
Creator: U.S. Food and Drug Administration
Published: 1984-10-01

Substantially Equivalent

Livonia Diagnostics, Inc.

FDA 510(k) clearance K843701 for TOTAL PROTEIN REAGENT SET, Substantially Equivalent on 1984-10-01. Applicant: Livonia Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Livonia Diagnostics, Inc.
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1984-09-21
Decision date: 1984-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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