510(k) K161899— 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 Curve Controls

Substantially Equivalent

Phadia AB

Clearance details

Applicant: Phadia AB
Product code: Code DGC
Advisory panel: Immunology
Date received: 2016-07-11
Decision date: 2016-07-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Uppsala, SE

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