TOBRAMYCIN (FPIA) CALIBRATOR KIT— 510(k) K861891

Name: FDA 510(k) clearance K861891
Creator: U.S. Food and Drug Administration
Published: 1986-06-25

Substantially Equivalent

Windsor Laboratories, Inc.

FDA 510(k) clearance K861891 for TOBRAMYCIN (FPIA) CALIBRATOR KIT, Substantially Equivalent on 1986-06-25. Applicant: Windsor Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Windsor Laboratories, Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1986-05-16
Decision date: 1986-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garland, TX, US

Download summary PDF View on FDA.gov ↗

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