RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201— 510(k) K881243

Name: FDA 510(k) clearance K881243
Creator: U.S. Food and Drug Administration
Published: 1988-04-04

Substantially Equivalent

Labsystems, Inc.

FDA 510(k) clearance K881243 for RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201, Substantially Equivalent on 1988-04-04. Applicant: Labsystems, Inc.. Device class: 2.

Clearance details

Applicant: Labsystems, Inc.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1988-03-21
Decision date: 1988-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morton Grove, IL, US

Download summary PDF View on FDA.gov ↗

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