510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN180030Unknown

QMS Plazomicin Immunoassay

Microgenics Corporation, Fremont CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN180030 is the FDA 510(k) clearance record for QMS Plazomicin Immunoassay, a class II device, cleared for Microgenics Corporation on under FDA product code QDR (Plazomicin Test System, Immunoassay). FDA's definition for product code QDR reads: "A plazomicin test system is a device intended to measure plazomicin in human specimens. Measurements obtained by this device are used in monitoring levels of plazomicin to ensure appropriate therapy in patients with complicated urinary...". FDA records list 128 510(k) clearances for Microgenics Corporation, from to . As of , FDA records show no recalls naming DEN180030.

Clearance record

Decision date
Received
(147 days to decision)
Product code
QDR Plazomicin Test System, Immunoassay
Regulation
21 CFR 862.3460
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Microgenics Corporation 46500 Kato Rd., Fremont CA
Third party review
No

Clearances, product code QDR

Trailing 12 months

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

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