ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR

Bromcresol Purple Dye-binding, Albumin

SIEMENS HEALTHCARE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Chemistry Albumin Bcp Reagent (albp), Advia Chemistry Albumin Bcp Calibrator.

Pre-market Notification Details

Device IDK132664
510k NumberK132664
Device Name:ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
ClassificationBromcresol Purple Dye-binding, Albumin
Applicant SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVE Tarrytown,  NY  10591
ContactKira Gordon
CorrespondentKira Gordon
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVE Tarrytown,  NY  10591
Product CodeCJW  
CFR Regulation Number862.1035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-27
Decision Date2013-10-16
Summary:summary

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