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510(k) K001761

STATLYTE NA/K/CL/LI ANALYZER by Nova Biomedical Corp. — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2000
Date Received
June 9, 2000
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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  • K041016 — NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS (May 7, 2004)

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