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510(k) K894914

MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK by I-Stat Corp. — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1989
Date Received
August 2, 1989
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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