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510(k) K113726

EPOC CHLORIDE TEST AND EPOC CREATININE TEST by Epocal, Inc. — Product Code CGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2012
Date Received
December 19, 2011
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 Epocal, Inc.

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  • K093297 — EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE (June 9, 2010)
  • K092849 — BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER (March 30, 2010)
  • K090109 — BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD (June 24, 2009)
  • K061597 — EPOC BLOOD ANALYSIS SYSTEM (September 27, 2006)

Other clearances for product code CGL

  • K171059 — Nova StatSensor Creatinine Hospital Meter System (May 26, 2017)
  • K070068 — NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS (May 7, 2007)
  • K051968 — ABL8X7 FLEX (October 16, 2006)
  • K991727 — STAT PROFILE M7 ANALYZER (July 16, 1999)
  • K973292 — I-STAT SYSTEM (October 20, 1997)
  • K903034 — RENALYZER PRX 90 (March 13, 1991)