510(k) K813523

ELECTRIC SELF STERILIZATION INOCUL. LOOP by Techhnilab Instruments, Inc. — Product Code LTB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
December 16, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cyclosporine Radioimmunoassay
Device Class
Class II
Regulation Number
862.1235
Review Panel
TX
Submission Type