SRI DIGOXIN ENZYME IMMUNOASSAY— 510(k) K915602

Substantially Equivalent

Serono-Baker Diagnostics, Inc.

FDA 510(k) clearance K915602 for SRI DIGOXIN ENZYME IMMUNOASSAY, Substantially Equivalent on 1992-01-17. Applicant: Serono-Baker Diagnostics, Inc..

Clearance details

Applicant: Serono-Baker Diagnostics, Inc.
Product code: Code KXT
Advisory panel: Clinical Toxicology
Date received: 1991-12-13
Decision date: 1992-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

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