510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K872575Substantially Equivalent

Hdl Cholesterol Reagent

Sigma Chemical Co., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872575 is the FDA 510(k) clearance record for HDL CHOLESTEROL REAGENT, a class I device, cleared for Sigma Chemical Co. on under FDA product code CHH (Enzymatic Esterase--Oxidase, Cholesterol). FDA records list 231 510(k) clearances for Sigma Chemical Co., from to . As of , FDA records show no recalls naming K872575.

Clearance record

Decision date
Received
(16 days to decision)
Product code
CHH Enzymatic Esterase--Oxidase, Cholesterol
Regulation
21 CFR 862.1175
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Sigma Chemical Co. P.O. Box 14508, St. Louis MO
Third party review
No

Clearances, product code CHH

Trailing 12 months
1 clearance under product code CHH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CHH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260