510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K893548Substantially Equivalent

Seralyzer Hdl Cholesterol Procedure Use W/strip

Kulzer GmbH, Elkhart IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893548 is the FDA 510(k) clearance record for SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP, a class I device, cleared for Heraeus Kulzer, Inc. on under FDA product code LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K893548.

Clearance record

Decision date
Received
(87 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
Heraeus Kulzer, Inc. Diagnostics Division, Elkhart IN
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