SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER— 510(k) K912494

Name: FDA 510(k) clearance K912494
Creator: U.S. Food and Drug Administration
Published: 1991-09-10

Substantially Equivalent

Toa Medical Electronics USA, Inc.

FDA 510(k) clearance K912494 for SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER, Substantially Equivalent on 1991-09-10. Applicant: Toa Medical Electronics USA, Inc.. Device class: 2.

Clearance details

Applicant: Toa Medical Electronics USA, Inc.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1991-06-05
Decision date: 1991-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Alamitos, CA, US

Download summary PDF View on FDA.gov ↗

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