510(k) K822716

UNIVERSAL CENTRIFUGE by Biodynamics Corp. — Product Code JPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1982
Date Received
September 7, 1982
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