510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K861244Substantially Equivalent

Hdl/cholesterol Test System

Chrometrics Laboratories, Inc., Park Ridge IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861244 is the FDA 510(k) clearance record for HDL/CHOLESTEROL TEST SYSTEM, a class I device, cleared for Chrometrics Laboratories, Inc. on under FDA product code LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl). FDA records list one 510(k) clearance for Chrometrics Laboratories, Inc. As of , FDA records show no recalls naming K861244.

Clearance record

Decision date
Received
(180 days to decision)
Product code
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Chrometrics Laboratories, Inc. 808 Busse Hwy., Park Ridge IL
Third party review
No

Clearances, product code LBS

Trailing 12 months

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

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