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510(k) K100031

IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 by Ind Diagnostic, Inc. — Product Code KHE

K100031 is an FDA 510(k) premarket notification submitted by Ind Diagnostic, Inc. for the device "IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10". The FDA issued a decision of Substantially Equivalent on July 19, 2010. The device falls under product code KHE (Reagent, Occult Blood), a Class II device regulated under 21 CFR 864.6550. Ind Diagnostic, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2010
Date Received
January 6, 2010
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 Ind Diagnostic, Inc.

  • K103037 — IND URINARY TRACT INFECTION (UTI) TEST STRIPS (April 17, 2012)
  • K063390 — URINE CHEMISTRY ANALYZER UR-50 (March 1, 2007)
  • K060810 — ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC (August 7, 2006)
  • K052694 — ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. (December 16, 2005)
  • K052662 — ONE STEP FSH MENOPAUSAL TEST (November 30, 2005)
  • K050741 — IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT (May 16, 2005)
  • K023638 — CASSETTE/URINE HCG (January 3, 2003)

Other clearances for product code KHE

  • K173212 — Instant-view-PLUS immunochemical Fecal Occult Blood Test (February 15, 2018)
  • K170548 — InSure ONE (October 5, 2017)
  • 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)

FDA data resources