SYSTEMATE BUN HEM NO. 67221— 510(k) K843326

Name: FDA 510(k) clearance K843326
Creator: U.S. Food and Drug Administration
Published: 1984-09-14

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K843326 for SYSTEMATE BUN HEM NO. 67221, Substantially Equivalent on 1984-09-14. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1984-08-27
Decision date: 1984-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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