COUNTER, BLOOD CELL & HEMATOCRIT— 510(k) K770034

Name: FDA 510(k) clearance K770034
Creator: U.S. Food and Drug Administration
Published: 1977-02-16

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K770034 for COUNTER, BLOOD CELL & HEMATOCRIT, Substantially Equivalent on 1977-02-16. 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: 1977-01-10
Decision date: 1977-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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