QMS AMIKACIN REAGENTS— 510(k) K052815

Substantially Equivalent

Seradyn, Inc.

FDA 510(k) clearance K052815 for QMS AMIKACIN REAGENTS, Substantially Equivalent on 2005-11-01. Applicant: Seradyn, Inc.. Device class: 2.

Clearance details

Applicant: Seradyn, Inc.
Product code: Code KLQ
Device class: Class 2
Regulation: 21 CFR 862.3035
Advisory panel: Clinical Toxicology
Date received: 2005-10-04
Decision date: 2005-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLQ

K033884 — RANDOX AMIKACIN2004-06-09
K955570 — INNOFLUOR AMIKACIN ASSAY SYSTEM1996-02-09
K903100 — INNOFLUOR (TM) AMIKACIN REAGENT SET1990-08-09
K894517 — FPR AMIKACIN KIT1989-09-28
K852317 — COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR1985-06-25

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
K060709 — MULTIGENT GENTAMICIN2006-06-15

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