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510(k) K936066

STAT PROFILE PLUS 9 ANALYZER by Nova Biomedical Corp. — Product Code KHP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1995
Date Received
December 21, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Lactic, Enzymatic Method
Device Class
Class I
Regulation Number
862.1450
Review Panel
CH
Submission Type

Other clearances by Nova Biomedical Corp.

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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 KHP

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  • K112430 — I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE (December 20, 2011)
  • K100602 — NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS (August 17, 2011)
  • K093297 — EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE (June 9, 2010)
  • K013938 — IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE (January 28, 2002)
  • K011478 — I-STAT SYSTEM (July 2, 2001)
  • K980908 — LACTATE PRO SYSTEM (September 11, 1998)
  • K982071 — I-STAT LACTATE TEST (June 29, 1998)