Home / 510(k) Clearances / K173704

510(k) K173704

ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip by Phadia AB — Product Code OYL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2018
Date Received
December 4, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tryptase Assay System
Device Class
Class II
Regulation Number
866.5760
Review Panel
IM
Submission Type

An in vitro diagnostic device intended as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings.

Other clearances by Phadia AB

  • K212181 — ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Alle (August 3, 2022)
  • K210902 — EliA Ro52, EliA Ro60 (July 27, 2022)
  • K202541 — EliA RNA Pol III (September 13, 2021)
  • K202540 — EliA Rib-P (September 13, 2021)
  • K202067 — EliA SmDP-S (July 14, 2021)
  • K200279 — ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, (May 1, 2020)
  • K190710 — EliA SymphonyS Immunoassay (November 29, 2019)
  • K190315 — ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e23 (May 14, 2019)
  • K181871 — EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG (March 1, 2019)
  • K183007 — EliA SmDP Immunoassay (December 24, 2018)

Other clearances for product code OYL

  • DEN120001 — IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, (February 15, 2012)