REAGENT CUPS

Analyzer, Chemistry, Centrifugal, For Clinical Use

AMERICAN SCIENTIFIC PRODUCTS

The following data is part of a premarket notification filed by American Scientific Products with the FDA for Reagent Cups.

Pre-market Notification Details

Device IDK831569
510k NumberK831569
Device Name:REAGENT CUPS
ClassificationAnalyzer, Chemistry, Centrifugal, For Clinical Use
Applicant AMERICAN SCIENTIFIC PRODUCTS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJG  
CFR Regulation Number862.2140 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-16
Decision Date1983-06-30

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