510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210801Substantially Equivalent

AXINON® LDL-p Test System

Numares AG, Regensburg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210801 is the FDA 510(k) clearance record for AXINON® LDL-p Test System, a class I device, cleared for Numares AG on under FDA product code MRR (System, Test, Low Density, Lipoprotein). FDA records list one 510(k) clearance for Numares AG. As of , FDA records show no recalls naming K210801.

Clearance record

Decision date
Received
(854 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
Numares AG Am Biopark 9, Regensburg, DE
510(k) summary
Summary PDF
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