ALKPHOR SYSTEM

Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

CALIFORNIA IMMUNO DIAGNOSTIC, INC.

The following data is part of a premarket notification filed by California Immuno Diagnostic, Inc. with the FDA for Alkphor System.

Pre-market Notification Details

Device IDK823445
510k NumberK823445
Device Name:ALKPHOR SYSTEM
ClassificationElectrophoretic Separation, Alkaline Phosphatase Isoenzymes
Applicant CALIFORNIA IMMUNO DIAGNOSTIC, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCIN  
CFR Regulation Number862.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-11-16
Decision Date1982-12-28

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