510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN120001Unknown

Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50, Calibrator Strip, Curve Control Strip, Anti-Tryptase

Phadia AB, Portage MI / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN120001 is the FDA 510(k) clearance record for IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE, a class II device, cleared for Phadia US, Inc. on under FDA product code OYL (Tryptase Assay System). FDA's definition for product code OYL 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". FDA records list 56 510(k) clearances for PHADIA AB, from to . As of , FDA records show no recalls naming DEN120001.

Clearance record

Decision date
Received
(34 days to decision)
Product code
OYL Tryptase Assay System
Regulation
21 CFR 866.5760
Device class
Class II
Review panel
Immunology
Applicant
Phadia US, Inc. 4169 Commercial Ave., Portage MI
Third party review
No

Clearances, product code OYL

Trailing 12 months

FDA records hold no clearances under product code OYL in the trailing twelve months.

FDA records show no clearances under product code OYL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OYL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260