STRATUS FLUOROMETRIC ENZYME IMMUN0-

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

AMERICAN HOSPITAL SUPPLY CORP.

The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Stratus Fluorometric Enzyme Immun0-.

Pre-market Notification Details

Device IDK830301
510k NumberK830301
Device Name:STRATUS FLUOROMETRIC ENZYME IMMUN0-
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJE  
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-01-28
Decision Date1983-02-25

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