510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K832460Substantially Equivalent

Triglyceride Reagent-Trinder-Gpo

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

K832460 is the FDA 510(k) clearance record for TRIGLYCERIDE REAGENT-TRINDER-GPO, a class I device, cleared for Seppim, Inc. on under FDA product code JGY (Colorimetric Method, Triglycerides). FDA records list one 510(k) clearance for Seppim, Inc. As of , FDA records show no recalls naming K832460.

Clearance record

Decision date
Received
(48 days to decision)
Product code
JGY Colorimetric Method, Triglycerides
Regulation
21 CFR 862.1705
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Seppim, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JGY

Trailing 12 months

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

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