FDA 510(k) Applications for Medical Device Product Code "OYL"

FDA 510(k) Number Applicant Device Name Decision Date
K173704 Phadia AB ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip 03/02/2018
DEN120001 PHADIA US INC. IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE 02/15/2012


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