ULTRAZYME PLUS ALP

Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

HARLECO DIAGNOSTICS

The following data is part of a premarket notification filed by Harleco Diagnostics with the FDA for Ultrazyme Plus Alp.

Pre-market Notification Details

Device IDK821870
510k NumberK821870
Device Name:ULTRAZYME PLUS ALP
ClassificationNitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant HARLECO DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCJE  
CFR Regulation Number862.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-06-25
Decision Date1982-07-13

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