OPUS PROCAINAMIDE— 510(k) K951434

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K951434 for OPUS PROCAINAMIDE, Substantially Equivalent on 1995-07-03. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code LAR
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1995-03-28
Decision date: 1995-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.