SYSMEX SE/RAM-1— 510(k) K964375

Substantially Equivalent

Sysmex Corp.

FDA 510(k) clearance K964375 for SYSMEX SE/RAM-1, Substantially Equivalent on 1997-03-13. Applicant: Sysmex Corp.. Device class: 2.

Clearance details

Applicant: Sysmex Corp.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1996-11-01
Decision date: 1997-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Long Grove, IL, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.