Home / 510(k) Clearances / K231151

510(k) K231151

Kenota 1 Total IgE; Kenota 1 (instrument) by Kenota, Inc. — Product Code DGC

K231151 is an FDA 510(k) premarket notification submitted by Kenota, Inc. for the device "Kenota 1 Total IgE; Kenota 1 (instrument)". The FDA issued a decision of Substantially Equivalent on May 31, 2024. The device falls under product code DGC (Ige, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2024
Date Received
April 24, 2023
Clearance Type
Dual Track
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ige, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances for product code DGC

  • K214068 — Quantia IgE (February 21, 2023)
  • K220178 — Total Immunoglobulin E (IgE) (March 23, 2022)
  • K193493 — ADVIA Centaur Total IgE (tIgE) (January 15, 2020)
  • K161899 — ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP To (July 28, 2016)
  • K133404 — IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL L (February 24, 2014)
  • K063425 — DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONT (February 15, 2007)
  • K050493 — QUANTIA IGE (August 16, 2005)
  • K042241 — K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C (December 10, 2004)
  • K034057 — LACRYTEST (March 9, 2004)
  • K032251 — IMMUNETECH TOTAL IGE SYSTEM (December 19, 2003)

FDA data resources