SYSTEM 9000 AUTOMATED CELL COUNTER— 510(k) K870603

Name: FDA 510(k) clearance K870603
Creator: U.S. Food and Drug Administration
Published: 1987-03-31

Substantially Equivalent

Baker Instructions Corp.

FDA 510(k) clearance K870603 for SYSTEM 9000 AUTOMATED CELL COUNTER, Substantially Equivalent on 1987-03-31. 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: 1987-02-11
Decision date: 1987-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winchester, VA, US

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