510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013152Substantially Equivalent

Atac Pak Direct Hdl Reagent and Atac Direct Hdl Calibrator Kits

Elan Holdings, Inc., Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013152 is the FDA 510(k) clearance record for ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS, a class I device, cleared for Elan Holdings, Inc. on under FDA product code LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl). FDA records list 12 510(k) clearances for Elan Holdings, Inc., from to . As of , FDA records show no recalls naming K013152.

Clearance record

Decision date
Received
(50 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
Elan Holdings, Inc. 1075 W. Lambert Rd., Brea CA
510(k) summary
Summary
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