EMIT 2000 GENTAMICIN PLUS ASSAY— 510(k) K010984

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..

Clearance details

Applicant: Syva Co., Dade Behring, Inc.
Product code: Code LCD
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

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