OPUS GENTAMICIN— 510(k) K905721

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K905721 for OPUS GENTAMICIN, Substantially Equivalent on 1991-02-21. Applicant: Pb Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code LCQ
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1990-12-21
Decision date: 1991-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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