TOBRAMYCIN FLEX REAGENT CARTRIDGE— 510(k) K962818

Name: FDA 510(k) clearance K962818
Creator: U.S. Food and Drug Administration
Published: 1996-09-13

Substantially Equivalent

Dade Intl., Inc.

FDA 510(k) clearance K962818 for TOBRAMYCIN FLEX REAGENT CARTRIDGE, Substantially Equivalent on 1996-09-13. Applicant: Dade Intl., Inc.. Device class: 2.

Clearance details

Applicant: Dade Intl., Inc.
Product code: Code LCR
Device class: Class 2
Regulation: 21 CFR 862.3900
Advisory panel: Clinical Toxicology
Date received: 1996-07-19
Decision date: 1996-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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