510(k) K790646

HELENA QUIPLATE SYSTEM by Helena Laboratories — Product Code JZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1979
Date Received
March 30, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plates And Equipment, Radial Immunodiffusion
Device Class
Class I
Regulation Number
866.4800
Review Panel
IM
Submission Type