SYSTEM 8000 CELL COUNTER— 510(k) K850386

Name: FDA 510(k) clearance K850386
Creator: U.S. Food and Drug Administration
Published: 1985-05-02

Substantially Equivalent

Baker Instructions Corp.

FDA 510(k) clearance K850386 for SYSTEM 8000 CELL COUNTER, Substantially Equivalent on 1985-05-02. Applicant: Baker Instructions Corp.. Device class: 2.

Clearance details

Applicant: Baker Instructions Corp.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1985-02-01
Decision date: 1985-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

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