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510(k) K973547

TRIAGE STATMETER by Biosite Incorporated — Product Code KHO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1998
Date Received
September 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometer, For Clinical Use
Device Class
Class I
Regulation Number
862.2560
Review Panel
CH
Submission Type

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