Dimension EXL LOCI BRAHMS Procalcitonin (PCT)

Procalcitonin Assay

Siemens Healthcare Diagnostics, Inc.

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Dimension Exl Loci Brahms Procalcitonin (pct).

Pre-market Notification Details

Device IDK220262
510k NumberK220262
Device Name:Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
ClassificationProcalcitonin Assay
Applicant Siemens Healthcare Diagnostics, Inc. 500 GBC Drive, P.O. Box 6101 Mail Stop 514 Newark,  DE  19714
ContactAmy Tyler
CorrespondentAmy Tyler
Siemens Healthcare Diagnostics, Inc. 500 GBC Drive, P.O. Box 6101 Mail Stop 514 Newark,  DE  19714
Product CodePRI  
CFR Regulation Number866.3215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-31
Decision Date2022-08-26

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