IMMULITE 2000 CEA Calibration Verification 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 Immulite 2000 Cea Calibration Verification Material.

Pre-market Notification Details

Device IDK143639
510k NumberK143639
Device Name:IMMULITE 2000 CEA Calibration Verification Material
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant Siemens Healthcare Diagnostics 511 Benedict Avenue Tarrytown,  NY  10591
ContactAsha Gartland
CorrespondentAsha Gartland
Siemens Healthcare Diagnostics 511 Benedict Avenue Tarrytown,  NY  10591
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-22
Decision Date2015-01-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414971179 K143639 000

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