MULTIGENT GENTAMICIN— 510(k) K060709

Substantially Equivalent

Seradyn, Inc.

FDA 510(k) clearance K060709 for MULTIGENT GENTAMICIN, Substantially Equivalent on 2006-06-15. Applicant: Seradyn, Inc.. Device class: 2.

Clearance details

Applicant: Seradyn, Inc.
Product code: Code LCD
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 2006-03-16
Decision date: 2006-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCD

K243500 — ARCHITECT iGentamicin2025-07-09
K102699 — ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS2011-04-01
K042479 — VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 142005-01-06
K020704 — ROCHE ONLINE GENTAMICIN2002-07-12
K012978 — RANDOX GENTAMICIN2001-09-18

More clearances from Seradyn, Inc.

K070645 — SERADYN QMS TOPIRAMATE2007-05-17
K062966 — QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS2007-01-12
K062204 — ARCHITECT CORTISOL ASSAY2006-09-22
K060998 — QMS TOBRAMYCIN2006-07-21
K052826 — QMS QUINIDINE. QMS QUINIDINE CALIBRATORS2005-12-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.