URIC ACID DIAGNOSTIC REAGENT— 510(k) K801898

Name: FDA 510(k) clearance K801898
Creator: U.S. Food and Drug Administration
Published: 1980-10-10

Substantially Equivalent

Connecticut Diagnostics, Ltd.

FDA 510(k) clearance K801898 for URIC ACID DIAGNOSTIC REAGENT, Substantially Equivalent on 1980-10-10. Applicant: Connecticut Diagnostics, Ltd.. Device class: 1.

Clearance details

Applicant: Connecticut Diagnostics, Ltd.
Product code: Code KNK
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1980-08-08
Decision date: 1980-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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