QMS TOBRAMYCIN— 510(k) K060998

Substantially Equivalent

Seradyn, Inc.

FDA 510(k) clearance K060998 for QMS TOBRAMYCIN, Substantially Equivalent on 2006-07-21. Applicant: Seradyn, Inc.. Device class: 2.

Clearance details

Applicant: Seradyn, Inc.
Product code: Code LCR
Device class: Class 2
Regulation: 21 CFR 862.3900
Advisory panel: Clinical Toxicology
Date received: 2006-04-11
Decision date: 2006-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCR

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K962818 — TOBRAMYCIN FLEX REAGENT CARTRIDGE1996-09-13
K952568 — BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT1995-08-08
K911940 — OPUS(R) TOBRAMYCIN1991-07-01
K911613 — VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.41991-06-28

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
K060709 — MULTIGENT GENTAMICIN2006-06-15
K052826 — QMS QUINIDINE. QMS QUINIDINE CALIBRATORS2005-12-23

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