510(k) K904761

P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT by Instrumentation Laboratory CO — Product Code CIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1990
Date Received
October 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Volumetric/Manometric, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type