510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061742Substantially Equivalent

Uryxxon Relax Urine Analyzer

Macherey Nagel GmbH & Co. KG, Rockville MD / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K061742 is the FDA 510(k) clearance record for URYXXON RELAX URINE ANALYZER, a class II device, cleared for Macherey-Nagel GmbH & Co. KG on under FDA product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)). FDA records list 2 510(k) clearances for Macherey-Nagel GmbH & Co. KG, from to . As of , FDA records show no recalls naming K061742.

Clearance record

Decision date
Received
(78 days to decision)
Product code
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Regulation
21 CFR 862.1340
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Macherey-Nagel GmbH & Co. KG 7361 Calhoun Pl., Suite 500, Rockville MD
510(k) summary
Statement
Third party review
No

Clearances, product code JIL

Trailing 12 months

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

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