URIC ACID STANDARD, 8MG/DL #65078— 510(k) K823147

Name: FDA 510(k) clearance K823147
Creator: U.S. Food and Drug Administration
Published: 1982-11-22

Substantially Equivalent

Harleco Diagnostics

FDA 510(k) clearance K823147 for URIC ACID STANDARD, 8MG/DL #65078, Substantially Equivalent on 1982-11-22. Applicant: Harleco Diagnostics. Device class: 2.

Clearance details

Applicant: Harleco Diagnostics
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1982-10-25
Decision date: 1982-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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