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510(k) K100031

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

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.

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  • 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

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  • 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)