K834021Substantially Equivalent

Sysmex Cc-780 Eight Parameter Aut0

Name: K834021 Sysmex Cc-780 Eight Parameter Aut0
Creator: Toa Medical Electronics USA, Inc.
Published: 1984-03-02
License: https://open.fda.gov/license/

Toa Medical Electronics USA, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K834021 is the FDA 510(k) clearance record for SYSMEX CC-780 EIGHT PARAMETER AUT0, cleared for Toa Medical Electronics USA, Inc. on 1984-03-02. FDA records list 33 510(k) clearances for Toa Medical Electronics USA, Inc., from 1978-05-19 to 1994-05-02. As of 2026-09-10, FDA records show no recalls naming K834021.

Clearance record

Decision date: 1984-03-02
Received: 1983-11-22 (101 days to decision)
Review panel: Unknown
Applicant: Toa Medical Electronics USA, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No