OPUS PHENYTOIN TEST SYSTEM— 510(k) K896868

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K896868 for OPUS PHENYTOIN TEST SYSTEM, Substantially Equivalent on 1990-01-02. Applicant: Pb Diagnostic Systems, Inc..

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code LGR
Advisory panel: Clinical Toxicology
Date received: 1989-12-07
Decision date: 1990-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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