510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K840243Substantially Equivalent

Determin. of Salicylate in Serum/plast

Sigma Chemical Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840243 is the FDA 510(k) clearance record for DETERMIN. OF SALICYLATE IN SERUM/PLAST, a class II device, cleared for Sigma Chemical Co. on under FDA product code DKJ (Colorimetry, Salicylate). FDA records list 231 510(k) clearances for Sigma Chemical Co., from to . As of , FDA records show no recalls naming K840243.

Clearance record

Decision date
Received
(63 days to decision)
Product code
DKJ Colorimetry, Salicylate
Regulation
21 CFR 862.3830
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Sigma Chemical Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DKJ

Trailing 12 months

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

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