Hemosure One-Step Fecal Occult Blood Test
FDA 510(k) K041202 · W.H.P.M., Inc.
510(k) numberK041202
Submission
- Device name
- Hemosure One-Step Fecal Occult Blood Test
- Applicant
- W.H.P.M., Inc.
Beverly, MA, US - Received
- May 7, 2004
- Decision date
- August 12, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KHE – Reagent, Occult Blood
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6550
- Specialty
- Hematology
Other 510(k)s with product code KHE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood TestKHE · Traditional | Alfa Scientific Designs, Inc. | 02/15/2018SE |
| K170548 | InSure ONEKHE · Traditional | Enterix, Inc. | 10/05/2017SE |
| K171484 | hema-screen SPECIFIC GoldKHE · Special | Immunostics Inc., | 06/14/2017SE |
| K162333 | Wondfo One Step Fecal Occult Blood (FOB) TestKHE · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 05/14/2017SE |
| K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestKHE · Special | Immunostics Inc., | 01/17/2017SE |
| K143325 | OC-Light S FITKHE · Traditional | Eiken Chemical Co., Ltd. | 08/20/2015SE |
| K121397 | Osom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit Osom Ifob 50 Test KitKHE · Traditional | SEKISUI Diagnostics, LLC | 12/28/2012SE |
| K113506 | Ind One Step Occult Blood (Fob) TestKHE · Special | Ind Diagnostics, Inc. | 12/19/2012SE |
| K110309 | Fob One Step Rapid TestKHE · Traditional | Orient Gene Biotech | 09/14/2011SE |
| K102664 | Hema Screen ErKHE · Special | Immunostics Inc., | 01/28/2011SE |
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| K171695 | First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of…NFT · Traditional | 02/05/2018SE |
| K160793 | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of…DJR · Traditional | 08/17/2016SE |
| K152551 | First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse…DJG · Traditional | 11/09/2015SE |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestDJR · Traditional | 06/29/2015SE |
| K150162 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestLAF · Traditional | 02/26/2015SE |
| K142353 | First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup TestDIO · Traditional | 10/07/2014SE |
| K052197 | First Sign Drug of Abuse Urine Screening TestDJR · Traditional | 06/09/2006SE |
| K051841 | WH Accu Test One-Step Urine/Serum Combo Pregnancy TestJHI · Traditional | 08/22/2005SE |
Questions and answers
When was Hemosure One-Step Fecal Occult Blood Test cleared by the FDA?
Hemosure One-Step Fecal Occult Blood Test (K041202) received a 510(k) decision of Substantially Equivalent on August 12, 2004, 97 days after the submission was received.
What is the product code of K041202?
The FDA product code is KHE – Reagent, Occult Blood, a Class II (moderate risk) device regulated under 21 CFR 864.6550.