SYSTEMATE T-BILI 67212— 510(k) K843328

Name: FDA 510(k) clearance K843328
Creator: U.S. Food and Drug Administration
Published: 1984-09-20

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K843328 for SYSTEMATE T-BILI 67212, Substantially Equivalent on 1984-09-20. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1984-08-27
Decision date: 1984-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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