510(k) K840767

HAEMOFUGE A. BIOFUGE A. & B by Heraeus-Christ GmbH — Product Code JPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1984
Date Received
February 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Hematocrit Measuring
Device Class
Class II
Regulation Number
864.6400
Review Panel
HE
Submission Type