MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7— 510(k) K063208

Name: FDA 510(k) clearance K063208
Creator: U.S. Food and Drug Administration
Published: 2007-01-19

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K063208 for MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7, Substantially Equivalent on 2007-01-19. Applicant: Diagnostic Chemicals , Ltd.. Device class: 1.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code JGJ
Device class: Class 1
Regulation: 21 CFR 862.1495
Advisory panel: Clinical Chemistry
Date received: 2006-10-23
Decision date: 2007-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E., CA

Download summary PDF View on FDA.gov ↗

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