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510(k) K200403

Stat Profile Prime Plus Analyzer System by Nova Biomedical Corporation — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2020
Date Received
February 19, 2020
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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  • K181201 — Synermed ISE Reagents (July 10, 2018)