RUBELLA IGM EIA TEST KIT— 510(k) K862431

Substantially Equivalent

Labsystems, Inc.

FDA 510(k) clearance K862431 for RUBELLA IGM EIA TEST KIT, Substantially Equivalent on 1986-08-08. 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: 1986-06-26
Decision date: 1986-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morton Grove, IL, US

Download summary PDF View on FDA.gov ↗

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