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510(k) K981427

STAT PROFILE M ANALYZER by Nova Biomedical Corp. — Product Code GKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1998
Date Received
April 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Hematocrit, Automated
Device Class
Class II
Regulation Number
864.5600
Review Panel
HE
Submission Type

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  • K091547 — NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE (January 15, 2010)
  • K070960 — NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM (July 11, 2007)
  • K070255 — NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 (June 13, 2007)
  • K070068 — NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS (May 7, 2007)
  • 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)

Other clearances for product code GKF

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  • K983551 — CRIT-SCAN II MONITOR (May 27, 1999)
  • K981426 — STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS (May 12, 1998)
  • K981425 — STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS (May 12, 1998)
  • K953519 — MICROSPIN 24 (November 3, 1995)
  • K915825 — MARATHON 6K GENERAL-PURPOSE CENTRIFUGE (March 11, 1992)
  • K915441 — MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE (January 8, 1992)
  • K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR (December 27, 1990)
  • K880373 — IONOMETER E-HK AND ACCESSORIES (March 17, 1988)
  • K870860 — CHEMPRO 1000(TM) (April 14, 1987)