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
K943150Substantially Equivalent

Direct Ldl Cholesterol Immunoseparation Reagent Kit

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

K943150 is the FDA 510(k) clearance record for DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT, a class I device, cleared for Genzyme Corp. on under FDA product code MRR (System, Test, Low Density, Lipoprotein). FDA records list 33 510(k) clearances for Genzyme Corp., from to . As of , FDA records show no recalls naming K943150.

Clearance record

Decision date
Received
(258 days to decision)
Product code
MRR System, Test, Low Density, Lipoprotein
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 MRR

Trailing 12 months

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

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