LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers

Procalcitonin Assay

DiaSorin Inc.

The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Brahms Pct Ii Gen, Liaison Control Brahms Pct Ii Gen, Liaison Brahms Pct Ii Gen Verifiers.

Pre-market Notification Details

Device IDK173683
510k NumberK173683
Device Name:LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers
ClassificationProcalcitonin Assay
Applicant DiaSorin Inc. 1951 Northwestern Ave. Stillwater,  MN  55082 -0285
ContactJohn C Walter
CorrespondentCarol A Depouw
DiaSorin Inc. 1951 Northwestern Ave. Stillwater,  MN  55082 -0285
Product CodePRI  
Subsequent Product CodeJJX
Subsequent Product CodeNTM
Subsequent Product CodePMT
CFR Regulation Number866.3215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-01
Decision Date2018-02-27
Summary:summary

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