GSP NEONATAL THYROXINE (T4)

Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC.

The following data is part of a premarket notification filed by Wallac Oy, A Subsidiary Of Perkinelmer, Inc. with the FDA for Gsp Neonatal Thyroxine (t4).

Pre-market Notification Details

Device IDK103484
510k NumberK103484
Device Name:GSP NEONATAL THYROXINE (T4)
ClassificationEnzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Applicant WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. 940 WINTER STREET Waltham,  MA  02451
ContactSusan K Hamann
CorrespondentSusan K Hamann
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. 940 WINTER STREET Waltham,  MA  02451
Product CodeKLI  
CFR Regulation Number862.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-26
Decision Date2011-04-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06438147312139 K103484 000

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