510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231151Substantially Equivalent

Kenota 1 Total IgE; Kenota 1 (instrument)

Kenota, Inc., Kitchener, CA / Dual Track, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231151 is the FDA 510(k) clearance record for Kenota 1 Total IgE; Kenota 1 (instrument), a class II device, cleared for Kenota, Inc. on under FDA product code DGC (Ige, Antigen, Antiserum, Control). FDA records list one 510(k) clearance for Kenota, Inc. As of , FDA records show no recalls naming K231151.

Clearance record

Decision date
Received
(403 days to decision)
Product code
DGC Ige, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Kenota, Inc. 335 Gage Ave. #1, Kitchener, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DGC

Trailing 12 months

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

FDA records show no clearances under product code DGC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DGC, 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