510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OYLClass II

Tryptase Assay System

21 CFR 866.5760 / Immunology
FDA source (opens on fda.gov)

OYL is the FDA product code for Tryptase Assay System, a class II device type, regulated under 21 CFR 866.5760. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OYL
Device name
Tryptase Assay System
FDA definition
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.
Regulation
21 CFR 866.5760
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code OYL

By decision year
2 clearances under product code OYL with a decision year between 2012 and 2018, 2012 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OYL by decision year
YearClearances
20121
20181

Applicants with the most clearances

Product code OYL
Applicants holding the most 510(k) clearances under product code OYL
ApplicantClearances
Phadia AB2

Companies listing this code with FDA

Companies whose registered establishments list this code