IMMPULSE THEOPHYLLINE ASSAY REAGENTS— 510(k) K840758

Substantially Equivalent

Paragon Diagnostics, Inc.

FDA 510(k) clearance K840758 for IMMPULSE THEOPHYLLINE ASSAY REAGENTS, Substantially Equivalent on 1984-04-04. Applicant: Paragon Diagnostics, Inc..

Clearance details

Applicant
Paragon Diagnostics, Inc.
Product code
Code LER
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
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