510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K760478Substantially Equivalent

Reagent, Bun (Urea Nitrogen) Determ.

Simmler & Son, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K760478 is the FDA 510(k) clearance record for REAGENT, BUN (UREA NITROGEN) DETERM., a class II device, cleared for Simmler & Son, Inc. on under FDA product code CDW (Diacetyl-Monoxime, Urea Nitrogen). FDA records list 14 510(k) clearances for Simmler & Son, Inc., from to . As of , FDA records show no recalls naming K760478.

Clearance record

Decision date
Received
(73 days to decision)
Product code
CDW Diacetyl-Monoxime, Urea Nitrogen
Regulation
21 CFR 862.1770
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Simmler & Son, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CDW

Trailing 12 months

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

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