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510(k) K051646

ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH by Pointe Scientific, Inc., — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2005
Date Received
June 21, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type

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  • K023860 — MICROALBUMIN REAGENT SET AND CALIBRATORS (April 28, 2003)
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