PARAMAX AMMONIA REAGENTT

Enzymatic Method, Ammonia

AMERICAN DADE

The following data is part of a premarket notification filed by American Dade with the FDA for Paramax Ammonia Reagentt.

Pre-market Notification Details

Device IDK840770
510k NumberK840770
Device Name:PARAMAX AMMONIA REAGENTT
ClassificationEnzymatic Method, Ammonia
Applicant AMERICAN DADE 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJIF  
CFR Regulation Number862.1065 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-01-28
Decision Date1984-04-04

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