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510(k) K170548

InSure ONE by Enterix, Inc. — Product Code KHE

K170548 is an FDA 510(k) premarket notification submitted by Enterix, Inc. for the device "InSure ONE". The FDA issued a decision of Substantially Equivalent on October 5, 2017. The device falls under product code KHE (Reagent, Occult Blood), a Class II device regulated under 21 CFR 864.6550. Enterix, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2017
Date Received
February 24, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Occult Blood
Device Class
Class II
Regulation Number
864.6550
Review Panel
HE
Submission Type

Other clearances by Enterix, Inc.

  • K060930 — INSURE II (May 4, 2006)
  • K002457 — !NSURE FECAL OCCULT BLOOD TEST (January 12, 2001)

Other clearances for product code KHE

  • K173212 — Instant-view-PLUS immunochemical Fecal Occult Blood Test (February 15, 2018)
  • K171484 — hema-screen SPECIFIC Gold (June 14, 2017)
  • K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test (May 14, 2017)
  • K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test (January 17, 2017)
  • K143325 — OC-Light S FIT (August 20, 2015)
  • K121397 — OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 (December 28, 2012)
  • K113506 — IND ONE STEP OCCULT BLOOD (FOB) TEST (December 19, 2012)
  • K110309 — FOB ONE STEP RAPID TEST (September 14, 2011)
  • K102664 — HEMA SCREEN ER (January 28, 2011)
  • K100031 — IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 (July 19, 2010)

FDA data resources