SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM— 510(k) K061879

Name: FDA 510(k) clearance K061879
Creator: U.S. Food and Drug Administration
Published: 2006-12-15

Substantially Equivalent

Hemodiagnostica, LLC

FDA 510(k) clearance K061879 for SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM, Substantially Equivalent on 2006-12-15. Applicant: Hemodiagnostica, LLC. Device class: 2.

Clearance details

Applicant: Hemodiagnostica, LLC
Product code: Code CFR
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 2006-07-03
Decision date: 2006-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Johns Island, SC, US

Download summary PDF View on FDA.gov ↗

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