510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K072523Substantially Equivalent

Diazyme Ldl-Cholesterol Reagent, Calibrator and Controls

General Atomics, Poway CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072523 is the FDA 510(k) clearance record for DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS, a class I device, cleared for General Atomics on under FDA product code LBR (Ldl & Vldl Precipitation, Hdl). FDA records list 6 510(k) clearances for General Atomics, from to . As of , FDA records show no recalls naming K072523.

Clearance record

Decision date
Received
(137 days to decision)
Product code
LBR Ldl & Vldl Precipitation, Hdl
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Applicant
General Atomics 12889 Gregg Ct., Poway CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LBR

Trailing 12 months

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

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