URISCAN OPTIMA II URINE ANALYZER— 510(k) K050801

Name: FDA 510(k) clearance K050801
Creator: U.S. Food and Drug Administration
Published: 2005-04-20

Substantially Equivalent

Yd Diagnostics

FDA 510(k) clearance K050801 for URISCAN OPTIMA II URINE ANALYZER, Substantially Equivalent on 2005-04-20. Applicant: Yd Diagnostics. Device class: 2.

Clearance details

Applicant: Yd Diagnostics
Product code: Product code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 2005-03-30
Decision date: 2005-04-20
Decision: Substantially Equivalent
Clearance type: Special
Location: La Canada, CA, US

Download summary PDF View on FDA.gov ↗

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