GSP INSTRUMENT AND GSP NEONATAL HTSH KIT

Radioimmunoassay, Thyroid-stimulating Hormone

PERKINELMER, INC.

The following data is part of a premarket notification filed by Perkinelmer, Inc. with the FDA for Gsp Instrument And Gsp Neonatal Htsh Kit.

Pre-market Notification Details

Device IDK090846
510k NumberK090846
Device Name:GSP INSTRUMENT AND GSP NEONATAL HTSH KIT
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis,  IN  46236
ContactKay A Taylor
CorrespondentKay A Taylor
PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis,  IN  46236
Product CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-30
Decision Date2009-09-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06438147312009 K090846 000
06438147311040 K090846 000

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