Forsure Ifob Duel Sample Fecal Occult Blood Test Device (for Professional and Home Use); (for Professional); (for Home T
FDA 510(k) K073431 · Tianjin New Bay Bioresearch Co., Ltd.
510(k) numberK073431
Submission
- Device name
- Forsure Ifob Duel Sample Fecal Occult Blood Test Device (for Professional and Home Use); (for Professional); (for Home T
- Applicant
- Tianjin New Bay Bioresearch Co., Ltd.
Carlsbad, CA, US - Received
- December 6, 2007
- Decision date
- January 14, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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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| K071489 | Homecheck Multiple Drug Cup TestDKZ · Traditional | 03/28/2008SE |
| K061617 | Forsure One Step Dip & Read (X) Drug Screen TestDKZ · Traditional | 11/22/2006SE |
| K052520 | Rapid Forsure One Step Multiple Drug (Up to 6) Screen Test Device for Amphetamine…DJG · Traditional | 04/24/2006SE |
| K052882 | Forsure Rapid One Step Multiple(X) Abuse Drug Screen Test Cup DeviceDKZ · Traditional | 02/15/2006SE |
| K052208 | Glucose PilotNBW · Traditional | 12/09/2005SE |
| K042988 | Rapid One Step Buprenorphine Test CardDJG · Traditional | 05/12/2005SE |
| K042990 | For Sure One Step Buprenorphine Test StripDJG · Traditional | 05/10/2005SE |
Questions and answers
When was Forsure Ifob Duel Sample Fecal Occult Blood Test Device (for Professional and Home Use); (for Professional); (for Home T cleared by the FDA?
Forsure Ifob Duel Sample Fecal Occult Blood Test Device (for Professional and Home Use); (for Professional); (for Home T (K073431) received a 510(k) decision of Substantially Equivalent on January 14, 2008, 39 days after the submission was received.
What is the product code of K073431?
The FDA product code is KHE – Reagent, Occult Blood, a Class II (moderate risk) device regulated under 21 CFR 864.6550.