K.D. COLORIMETRIC BLOOD UREA N2 TEST— 510(k) K820418

Name: FDA 510(k) clearance K820418
Creator: U.S. Food and Drug Administration
Published: 1982-03-11

Substantially Equivalent

King Diagnostics, Inc.

FDA 510(k) clearance K820418 for K.D. COLORIMETRIC BLOOD UREA N2 TEST, Substantially Equivalent on 1982-03-11. Applicant: King Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: King Diagnostics, Inc.
Product code: Code JGZ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1982-02-16
Decision date: 1982-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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