DIRECT BILIRUBIN REAGENT

Diazo Colorimetry, Bilirubin

INTERSECT SYSTEMS, INC.

The following data is part of a premarket notification filed by Intersect Systems, Inc. with the FDA for Direct Bilirubin Reagent.

Pre-market Notification Details

Device IDK011972
510k NumberK011972
Device Name:DIRECT BILIRUBIN REAGENT
ClassificationDiazo Colorimetry, Bilirubin
Applicant INTERSECT SYSTEMS, INC. P.O. BOX 2219 Longview,  WA  98632
ContactMark E Legaz
CorrespondentMark E Legaz
INTERSECT SYSTEMS, INC. P.O. BOX 2219 Longview,  WA  98632
Product CodeCIG  
CFR Regulation Number862.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-25
Decision Date2001-08-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851445007204 K011972 000
00851445007198 K011972 000

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