EMIT 2000 GENTAMICIN PLUS ASSAY— 510(k) K010984

Name: FDA 510(k) clearance K010984
Creator: U.S. Food and Drug Administration
Published: 2001-04-20

Substantially Equivalent

Syva Co., Dade Behring, Inc.

FDA 510(k) clearance K010984 for EMIT 2000 GENTAMICIN PLUS ASSAY, Substantially Equivalent on 2001-04-20. Applicant: Syva Co., Dade Behring, Inc.. Device class: 2.

Clearance details

Applicant: Syva Co., Dade Behring, Inc.
Product code: Code LCD
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 2001-04-02
Decision date: 2001-04-20
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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