510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860154Substantially Equivalent

Bun (Enzymatic Berthelot) Reagent Set

Sterling Diagnostics, Inc., Sterling Heights MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860154 is the FDA 510(k) clearance record for BUN (ENZYMATIC BERTHELOT) REAGENT SET, a class II device, cleared for Sterling Diagnostics, Inc. on under FDA product code CDL (Berthelot Indophenol, Urea Nitrogen). FDA records list 41 510(k) clearances for Sterling Diagnostics, Inc., from to . As of , FDA records show one recall naming K860154.

Clearance record

Decision date
Received
(21 days to decision)
Product code
CDL Berthelot Indophenol, Urea Nitrogen
Regulation
21 CFR 862.1770
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Sterling Diagnostics, Inc. 34210 Dequindre Rd., Sterling Heights MI
Third party review
No

Clearances, product code CDL

Trailing 12 months

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

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