LOCI 8 CALIBRATOR, MODEL KC 646

Calibrator, Multi-analyte Mixture

SIEMENS HEALTHCARE DIAGNOSTICS

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Loci 8 Calibrator, Model Kc 646.

Pre-market Notification Details

Device IDK101460
510k NumberK101460
Device Name:LOCI 8 CALIBRATOR, MODEL KC 646
ClassificationCalibrator, Multi-analyte Mixture
Applicant SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 Newark,  DE  19714 -6101
ContactAnna Marie Ennis
CorrespondentAnna Marie Ennis
SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 Newark,  DE  19714 -6101
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-05-26
Decision Date2010-07-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768026492 K101460 000

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