NEONATAL BIOTINIDASE KIT, MODEL 3018

System, Test, Biotinidase

PERKINELMER, INC.

The following data is part of a premarket notification filed by Perkinelmer, Inc. with the FDA for Neonatal Biotinidase Kit, Model 3018.

Pre-market Notification Details

Device IDK090123
510k NumberK090123
Device Name:NEONATAL BIOTINIDASE KIT, MODEL 3018
ClassificationSystem, Test, Biotinidase
Applicant PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis,  IN  46236
ContactKay A Taylor
CorrespondentKay A Taylor
PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis,  IN  46236
Product CodeNAK  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number862.1118 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-01-21
Decision Date2010-03-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06438147291359 K090123 000
06438147291342 K090123 000

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