ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Cu

Ige, Antigen, Antiserum, Control

PHADIA AB

The following data is part of a premarket notification filed by Phadia Ab with the FDA for Immunocap Total Ige Calibrator Strip/total Ige Curve Control Strip, Immunocap Total Ige Calibrators/total Ige Curve Controls, Immunocap Specific Ige Calibrator Strip/specific Ige Curve Control Strip, Immunocap Specific Ige Calibrators/specific Ige Cu.

Pre-market Notification Details

Device IDK161899
510k NumberK161899
Device Name:ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Cu
ClassificationIge, Antigen, Antiserum, Control
Applicant PHADIA AB RAPSGATAN 7P Uppsala,  SE 75137
ContactUlf Karlberg
CorrespondentMartin Mann
PHADIA US INC. 4169 COMMERCIAL AVE. Portage,  MI  49002
Product CodeDGC  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-11
Decision Date2016-07-28
Summary:summary

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