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510(k) K141265

ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT by Elitechgroup — Product Code JHW

K141265 is an FDA 510(k) premarket notification submitted by Elitechgroup for the device "ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT". The FDA issued a decision of Substantially Equivalent on July 18, 2014. The device falls under product code JHW (U.V. Method, Cpk Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Elitechgroup has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2014
Date Received
May 15, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
U.V. Method, Cpk Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by Elitechgroup

  • K180559 — HSV 1 & 2 ELITe MGB Kit; ELITe InGenius (October 29, 2018)
  • K180627 — Macroduct Advanced Model 3710 (July 27, 2018)
  • K171401 — ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN (July 11, 2017)
  • K153644 — ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITe (September 7, 2016)
  • K151113 — ELITech Clinical Systems CALCIUM ARSENAZO (July 22, 2015)
  • K151552 — ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech C (July 8, 2015)
  • K132399 — ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, (January 3, 2014)
  • K130765 — ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH C (April 4, 2013)
  • K122177 — ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CL (February 15, 2013)
  • K122858 — ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINIC (October 3, 2012)

Other clearances for product code JHW

  • K162526 — Creatine Kinase-MB (May 26, 2017)
  • K122083 — ELITECH CLINICAL SYSTEMS CK NAC SL (August 22, 2012)
  • K023744 — WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 (January 3, 2003)
  • K003158 — ROCHE DIAGNOSTICS CK-MB (December 18, 2000)
  • K961501 — ELECSYS CK-MB (June 11, 1996)
  • K950186 — CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (March 13, 1995)
  • K944325 — LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN (February 22, 1995)
  • K942958 — CREATINE KINASE MB DETERMINATION (UV) (November 21, 1994)
  • K935924 — AXSYM CK-MB (June 21, 1994)
  • K931050 — CARDIO REP CK ISOENZYME KIT - 3310 (April 20, 1993)

FDA data resources