OPUS DIGITOXIN— 510(k) K935229

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K935229 for OPUS DIGITOXIN, Substantially Equivalent on 1993-12-22. Applicant: Pb Diagnostic Systems, Inc..

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code DPG
Advisory panel: Clinical Toxicology
Date received: 1993-11-01
Decision date: 1993-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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