GENETIC SYSTEMS MICROPLATE READER

Colorimeter, Photometer, Spectrophotometer For Clinical Use

GENETIC SYSTEMS CORP.

The following data is part of a premarket notification filed by Genetic Systems Corp. with the FDA for Genetic Systems Microplate Reader.

Pre-market Notification Details

Device IDK891767
510k NumberK891767
Device Name:GENETIC SYSTEMS MICROPLATE READER
ClassificationColorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle,  WA  98121
ContactMonica S Krieger
CorrespondentMonica S Krieger
GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle,  WA  98121
Product CodeJJQ  
CFR Regulation Number862.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-24
Decision Date1989-07-25

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