Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method— 510(k) K151487

Name: FDA 510(k) clearance K151487
Creator: U.S. Food and Drug Administration
Published: 2016-01-14

Substantially Equivalent

Diatron U.S., Inc.

FDA 510(k) clearance K151487 for Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method, Substantially Equivalent on 2016-01-14. Applicant: Diatron U.S., Inc.. Device class: 2.

Clearance details

Applicant: Diatron U.S., Inc.
Product code: Code CFR
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 2015-06-02
Decision date: 2016-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

Download summary PDF View on FDA.gov ↗

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