510(k) K790986

RF CONTROLS by Wampole Laboratories — Product Code DMR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1979
Date Received
May 25, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, M-Nitrophenol, Specific Reagent For Cholinesterase
Device Class
Class I
Regulation Number
862.3240
Review Panel
TX
Submission Type