FPR AMIKACIN KIT— 510(k) K894517

Substantially Equivalent

Colony Laboratories, Inc.

FDA 510(k) clearance K894517 for FPR AMIKACIN KIT, Substantially Equivalent on 1989-09-28. Applicant: Colony Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Colony Laboratories, Inc.
Product code: Code KLQ
Device class: Class 2
Regulation: 21 CFR 862.3035
Advisory panel: Clinical Toxicology
Date received: 1989-07-20
Decision date: 1989-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLQ

K052815 — QMS AMIKACIN REAGENTS2005-11-01
K033884 — RANDOX AMIKACIN2004-06-09
K955570 — INNOFLUOR AMIKACIN ASSAY SYSTEM1996-02-09
K903100 — INNOFLUOR (TM) AMIKACIN REAGENT SET1990-08-09
K852317 — COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR1985-06-25

More clearances from Colony Laboratories, Inc.

K894518 — FPR AMIKACIN CALIBRATOR KIT1989-09-28
K894523 — FPR GENTAMICIN KIT1989-09-28
K894524 — FPR GENTAMICIN CALIBRATOR KIT1989-09-28
K894521 — FPR DIGOXIN KIT1989-09-25
K894522 — FPR DIGOXIN CALIBRATOR KIT1989-09-25

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