510(k) K953519

MICROSPIN 24 by Vulcon Technologies — Product Code GKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1995
Date Received
July 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Hematocrit, Automated
Device Class
Class II
Regulation Number
864.5600
Review Panel
HE
Submission Type