INNOFLUOR GENTAMICIN ASSAY SYSTEM— 510(k) K972331

Name: FDA 510(k) clearance K972331
Creator: U.S. Food and Drug Administration
Published: 1997-08-01

Substantially Equivalent

Oxis Intl., Inc.

FDA 510(k) clearance K972331 for INNOFLUOR GENTAMICIN ASSAY SYSTEM, Substantially Equivalent on 1997-08-01. Applicant: Oxis Intl., Inc.. Device class: 2.

Clearance details

Applicant: Oxis Intl., Inc.
Product code: Code LGQ
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 1997-06-23
Decision date: 1997-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

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