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510(k) K991727

STAT PROFILE M7 ANALYZER by Nova Biomedical Corp. — Product Code CGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1999
Date Received
May 20, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Based, Enzymatic, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Nova Biomedical Corp.

  • K100602 — NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS (August 17, 2011)
  • K101633 — NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH (August 27, 2010)
  • 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 CGL

  • K171059 — Nova StatSensor Creatinine Hospital Meter System (May 26, 2017)
  • K113726 — EPOC CHLORIDE TEST AND EPOC CREATININE TEST (October 5, 2012)
  • K070068 — NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS (May 7, 2007)
  • K051968 — ABL8X7 FLEX (October 16, 2006)
  • K973292 — I-STAT SYSTEM (October 20, 1997)
  • K903034 — RENALYZER PRX 90 (March 13, 1991)