CMVGEN— 510(k) K974456

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K974456 for CMVGEN, Substantially Equivalent on 1998-05-01. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code LJO
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1997-11-25
Decision date: 1998-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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