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510(k) DEN120001

IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE by Phadia US, Inc. — Product Code OYL

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
February 15, 2012
Date Received
January 12, 2012
Clearance Type
Post-NSE
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.

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Other clearances for product code OYL

  • K173704 — ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Con (March 2, 2018)