510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K843180Substantially Equivalent

Salicylate Test

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

K843180 is the FDA 510(k) clearance record for SALICYLATE TEST, a class II device, cleared for Sclavo, Inc. on under FDA product code DKJ (Colorimetry, Salicylate). FDA records list 82 510(k) clearances for Sclavo, Inc., from to . As of , FDA records show no recalls naming K843180.

Clearance record

Decision date
Received
(25 days to decision)
Product code
DKJ Colorimetry, Salicylate
Regulation
21 CFR 862.3830
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Sclavo, Inc. 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