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510(k) K180627

Macroduct Advanced Model 3710 by Elitechgroup, Inc. — Product Code KTB

K180627 is an FDA 510(k) premarket notification submitted by Elitechgroup, Inc. for the device "Macroduct Advanced Model 3710". The FDA issued a decision of Substantially Equivalent on July 27, 2018. The device falls under product code KTB (Device, Iontophoresis, Specific Uses), a Class II device regulated under 21 CFR 890.5525. Elitechgroup, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2018
Date Received
March 9, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Specific Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
Submission Type

Other clearances by Elitechgroup, Inc.

  • K180559 — HSV 1 & 2 ELITe MGB Kit; ELITe InGenius (October 29, 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)
  • K141265 — ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT (July 18, 2014)
  • 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 KTB

  • K033192 — RH-950 (December 22, 2003)
  • K031551 — NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) (August 20, 2003)
  • K031115 — RH-900 (July 10, 2003)
  • K010031 — NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM (March 20, 2001)
  • K001522 — TRANSQ3 (October 18, 2000)
  • K001410 — PHORESOR MODEL PM2000 (August 1, 2000)
  • K992874 — Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM (November 18, 1999)
  • K974855 — PHORESOR II, MODEL PM900 (March 27, 1998)
  • K954126 — TRANSQ ELECTRODE PHORESOR II (January 19, 1996)
  • K895775 — CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM (April 23, 1990)

FDA data resources