IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)

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 Lh Calibration Verification Material (cvm), Immulite 2000 Free T3 Calibration Verification Material (cvm), Immulite 2000 Gastrin Calibration Verification Material (cvm).

Pre-market Notification Details

Device IDK142811
510k NumberK142811
Device Name:IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown,  NY  10591
ContactAsha Gartland
CorrespondentAsha Gartland
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown,  NY  10591
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-29
Decision Date2014-10-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414973715 K142811 000
00630414973630 K142811 000
00630414973593 K142811 000

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