OPUS CMV TEST SYSTEM-MODIFICATION— 510(k) K963084

Name: FDA 510(k) clearance K963084
Creator: U.S. Food and Drug Administration
Published: 1996-10-09

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K963084 for OPUS CMV TEST SYSTEM-MODIFICATION, Substantially Equivalent on 1996-10-09. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1996-08-08
Decision date: 1996-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

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