DeviceClearance

SYSMEX CA-6000— 510(k) K964139

Substantially Equivalent

Dade Intl., Inc.

FDA 510(k) clearance K964139 for SYSMEX CA-6000, Substantially Equivalent on 1997-02-06. Applicant: Dade Intl., Inc.. Device class: 2.

Clearance details

Applicant
Dade Intl., Inc.
Product code
Code GKP
Device class
Class 2
Regulation
21 CFR 864.5400
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Miami, FL, US
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