510(k) K926066

BION MUMPS-G ANTIBODY TEST SYSTEM by Bion Ent., Ltd. — Product Code CAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1993
Date Received
December 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Spinal-Fluid Pressure, Electrically Powered
Device Class
Class II
Regulation Number
880.2460
Review Panel
HO
Submission Type