510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K050632Substantially Equivalent

Advia Ims Direct Hdl Cholesterol Assay

Medrad, Inc., Tarrytown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050632 is the FDA 510(k) clearance record for ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY, a class I device, cleared for Bayer Healthcare, LLC on under FDA product code LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl). FDA records list 177 510(k) clearances for Medrad, Inc., from to . As of , FDA records show no recalls naming K050632.

Clearance record

Decision date
Received
(78 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
Bayer Healthcare, LLC 511 Benedict Ave., Tarrytown NY
510(k) summary
Summary PDF
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LBS, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260