CYTOMEGALOVIRUS IGG EIA TEST KIT— 510(k) K843189

Name: FDA 510(k) clearance K843189
Creator: U.S. Food and Drug Administration
Published: 1986-01-08

Substantially Equivalent

Labsystems, Inc.

FDA 510(k) clearance K843189 for CYTOMEGALOVIRUS IGG EIA TEST KIT, Substantially Equivalent on 1986-01-08. Applicant: Labsystems, Inc.. Device class: 2.

Clearance details

Applicant: Labsystems, Inc.
Product code: Code GQI
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1984-08-13
Decision date: 1986-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: IL, US

Download summary PDF View on FDA.gov ↗

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