IMMULITE 2000 PSA 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 Psa Calibration Verification Material.

Pre-market Notification Details

Device IDK131536
510k NumberK131536
Device Name:IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown,  NY  10591
ContactGaro Mimaryan
CorrespondentGaro Mimaryan
Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown,  NY  10591
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-29
Decision Date2013-08-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414601946 K131536 000

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