OPUS NAPA— 510(k) K934705

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K934705 for OPUS NAPA, Substantially Equivalent on 1993-11-22. Applicant: Pb Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code LAN
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1993-09-30
Decision date: 1993-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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