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MZU — System, Test, Sodium, Enzymatic Method Class II

FDA Device Classification

FDA product code MZU covers "System, Test, Sodium, Enzymatic Method", a Class II medical device regulated under 21 CFR 862.1665. Submissions are reviewed by the Clinical Chemistry panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MZU
Device Class
Class II
Regulation Number
862.1665
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K082763diazyme laboratoriesDIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114BNovember 12, 2008
K042189diazyme laboratoriesDIAZYME SODIUM ENZYMATIC ASSAYOctober 7, 2004

FDA data resources