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510(k) K041202

HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST by W.H.P.M., Inc. — Product Code KHE

K041202 is an FDA 510(k) premarket notification submitted by W.H.P.M., Inc. for the device "HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST". The FDA issued a decision of Substantially Equivalent on August 12, 2004. The device falls under product code KHE (Reagent, Occult Blood), a Class II device regulated under 21 CFR 864.6550. W.H.P.M., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2004
Date Received
May 7, 2004
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 W.H.P.M., Inc.

  • K200754 — Hemosure Accu-Reader A100 (June 2, 2022)
  • K210327 — First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign (August 12, 2021)
  • K171695 — First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign (February 5, 2018)
  • K160793 — First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign D (August 17, 2016)
  • K152551 — First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Bupr (November 9, 2015)
  • K151441 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (June 29, 2015)
  • K150162 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (February 26, 2015)
  • K142353 — First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test (October 7, 2014)
  • K052197 — FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST (June 9, 2006)
  • K051841 — WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST (August 22, 2005)

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)

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