510(k) K843440

MINGO LOG 7 by Siemens Elema AB — Product Code DJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1984
Date Received
September 4, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatography, Phenobarbital
Device Class
Class II
Regulation Number
862.3660
Review Panel
TX
Submission Type