ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL

Single (specified) Analyte Controls (assayed And Unassayed)

SIEMENS HEALTHCARE DIAGNOSTICS

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Enhanced Estradiol (ee2) Master Curve Material.

Pre-market Notification Details

Device IDK102904
510k NumberK102904
Device Name:ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE Tarrytown,  NY  10591 -5097
ContactClare Santulli
CorrespondentClare Santulli
SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE Tarrytown,  NY  10591 -5097
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-01
Decision Date2010-11-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414598888 K102904 000
00630414578972 K102904 000

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