FPR GENTAMICIN CALIBRATOR KIT— 510(k) K894524

Name: FDA 510(k) clearance K894524
Creator: U.S. Food and Drug Administration
Published: 1989-09-28

Substantially Equivalent

Colony Laboratories, Inc.

FDA 510(k) clearance K894524 for FPR GENTAMICIN CALIBRATOR KIT, Substantially Equivalent on 1989-09-28. Applicant: Colony Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Colony Laboratories, Inc.
Product code: Code DLG
Device class: Class 1
Regulation: 21 CFR 862.2250
Advisory panel: Clinical Chemistry
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 ↗

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