ACS DIGITOXIN— 510(k) K970546

Substantially Equivalent

Chiron Diagnostics Corp.

FDA 510(k) clearance K970546 for ACS DIGITOXIN, Substantially Equivalent on 1997-07-14. Applicant: Chiron Diagnostics Corp..

Clearance details

Applicant: Chiron Diagnostics Corp.
Product code: Code LFM
Advisory panel: Clinical Toxicology
Date received: 1997-02-12
Decision date: 1997-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

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