I.C.L.S. COMPULYZER— 510(k) K854055

Name: FDA 510(k) clearance K854055
Creator: U.S. Food and Drug Administration
Published: 1985-11-19

Substantially Equivalent

Integrated Computerized Laboratory Systems, Inc.

FDA 510(k) clearance K854055 for I.C.L.S. COMPULYZER, Substantially Equivalent on 1985-11-19. Applicant: Integrated Computerized Laboratory Systems, Inc.. Device class: 1.

Clearance details

Applicant: Integrated Computerized Laboratory Systems, Inc.
Product code: Code JJG
Device class: Class 1
Regulation: 21 CFR 862.2140
Advisory panel: Clinical Chemistry
Date received: 1985-10-03
Decision date: 1985-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roanoke, VA, US

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