IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material

Single (specified) Analyte Controls (assayed And Unassayed)

SIEMENS HEALTHCARE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Immulite 2000 Ferritin Calibration Verification Material, Immulite 2000 Igfbp-3 Calibration Verification Material.

Pre-market Notification Details

Device IDK143352
510k NumberK143352
Device Name:IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVENUE Tarrytown,  NY  10591
ContactSara Kastrup
CorrespondentSara Kastrup
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVENUE Tarrytown,  NY  10591
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-24
Decision Date2014-12-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414979403 K143352 000
00630414971254 K143352 000

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