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510(k) K960120

STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS by Nova Biomedical Corp. — Product Code JFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1996
Date Received
January 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

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  • K063821 — NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM (January 24, 2007)
  • K061830 — STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ (November 1, 2006)
  • K060345 — NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS (April 28, 2006)
  • K041016 — NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS (May 7, 2004)

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