IMMPULSE AMIKACIN ASSAY REAGENTS— 510(k) K841161

Substantially Equivalent

Paragon Diagnostics, Inc.

FDA 510(k) clearance K841161 for IMMPULSE AMIKACIN ASSAY REAGENTS, Substantially Equivalent on 1984-05-02. Applicant: Paragon Diagnostics, Inc..

Clearance details

Applicant: Paragon Diagnostics, Inc.
Product code: Code KLQ
Advisory panel: Clinical Toxicology
Date received: 1984-03-19
Decision date: 1984-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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