OPUS(TM) DIGOXIN TEST SYSTEM— 510(k) K901547

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K901547 for OPUS(TM) DIGOXIN TEST SYSTEM, Substantially Equivalent on 1990-06-26. Applicant: Pb Diagnostic Systems, Inc..

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code KXT
Advisory panel: Clinical Toxicology
Date received: 1990-04-03
Decision date: 1990-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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