EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS— 510(k) K962519

Name: FDA 510(k) clearance K962519
Creator: U.S. Food and Drug Administration
Published: 1996-09-04

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K962519 for EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS, Substantially Equivalent on 1996-09-04. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code LCD
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1996-06-27
Decision date: 1996-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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