510(k) K883586

TECHNICON RA-100 SYSTEM POTASSIUM by Technicon Instruments Corp. — Product Code CEJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1988
Date Received
August 23, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tetraphenyl Borate, Colorimetry, Potassium
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type