Cleared Special

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

K161899 · Phadia AB · Immunology

Jul 2016

Decision

17d

Days

Class 2

Risk

About This 510(k) Submission

K161899 is an FDA 510(k) clearance for the 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, a Ige, Antigen, Antiserum, Control (Class II — Special Controls, product code DGC), submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on July 28, 2016, 17 days after receiving the submission on July 11, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number	K161899 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 2016
Decision Date	July 28, 2016
Days to Decision	17 days
Submission Type	Special
Review Panel	Immunology (IM)
Summary	Summary PDF