DIGOXIN ENZYME IMMUNOASSAY— 510(k) K963835

Substantially Equivalent

Diagnostic Reagents, Inc.

FDA 510(k) clearance K963835 for DIGOXIN ENZYME IMMUNOASSAY, Substantially Equivalent on 1996-12-10. Applicant: Diagnostic Reagents, Inc..

Clearance details

Applicant: Diagnostic Reagents, Inc.
Product code: Code KXT
Advisory panel: Clinical Toxicology
Date received: 1996-09-24
Decision date: 1996-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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