PROFILE 750 BLOOD CELL COUNTER— 510(k) K823886

Name: FDA 510(k) clearance K823886
Creator: U.S. Food and Drug Administration
Published: 1983-03-01

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K823886 for PROFILE 750 BLOOD CELL COUNTER, Substantially Equivalent on 1983-03-01. Applicant: Mallinckrodt Critical Care. Device class: 2.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1982-12-27
Decision date: 1983-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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