510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971190Substantially Equivalent

N-Geneous Hdl Cholesterol Kit/cholesterol Calibrator

Genzyme Corporation, Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971190 is the FDA 510(k) clearance record for N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR, a class I device, cleared for Genzyme Corp. on under FDA product code LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl). FDA records list 33 510(k) clearances for Genzyme Corp., from to . As of , FDA records show no recalls naming K971190.

Clearance record

Decision date
Received
(77 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
Genzyme Corp. One Kendall Sq., Cambridge MA
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