DIGENE DML 2000 MICROPLATE LUMINOMETER

Colorimeter, Photometer, Spectrophotometer For Clinical Use

DIGENE CORP.

The following data is part of a premarket notification filed by Digene Corp. with the FDA for Digene Dml 2000 Microplate Luminometer.

Pre-market Notification Details

Device IDK980120
510k NumberK980120
Device Name:DIGENE DML 2000 MICROPLATE LUMINOMETER
ClassificationColorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant DIGENE CORP. 9000 VIRGINIA MANOR RD., Beltsville,  MD  20705
ContactConstance A Finch
CorrespondentConstance A Finch
DIGENE CORP. 9000 VIRGINIA MANOR RD., Beltsville,  MD  20705
Product CodeJJQ  
CFR Regulation Number862.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-13
Decision Date1998-02-06
Summary:summary

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