COMPUR* M1100 HEMATRCRIT SYSTEM— 510(k) K831318

Name: FDA 510(k) clearance K831318
Creator: U.S. Food and Drug Administration
Published: 1983-06-08

Substantially Equivalent

Worthington Diagnostic Systems

FDA 510(k) clearance K831318 for COMPUR* M1100 HEMATRCRIT SYSTEM, Substantially Equivalent on 1983-06-08. Applicant: Worthington Diagnostic Systems. Device class: 2.

Clearance details

Applicant: Worthington Diagnostic Systems
Product code: Code JPI
Device class: Class 2
Regulation: 21 CFR 864.6400
Advisory panel: Hematology
Date received: 1983-04-22
Decision date: 1983-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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