SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM— 510(k) K882767

Name: FDA 510(k) clearance K882767
Creator: U.S. Food and Drug Administration
Published: 1988-07-18

Substantially Equivalent

Toa Medical Electronics USA, Inc.

FDA 510(k) clearance K882767 for SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM, Substantially Equivalent on 1988-07-18. Applicant: Toa Medical Electronics USA, Inc.. Device class: 1.

Clearance details

Applicant: Toa Medical Electronics USA, Inc.
Product code: Code GKH
Device class: Class 1
Regulation: 21 CFR 864.5240
Advisory panel: Hematology
Date received: 1988-07-06
Decision date: 1988-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Alamitos, CA, US

Download summary PDF View on FDA.gov ↗

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