Ind One Step Fecal Occult Blood Test Model 440-10
FDA 510(k) K100031 · Ind Diagnostic, Inc.
510(k) numberK100031
Submission
- Device name
- Ind One Step Fecal Occult Blood Test Model 440-10
- Applicant
- Ind Diagnostic, Inc.
Delta, B.C., CA - Received
- January 6, 2010
- Decision date
- July 19, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
More from Immunostics Inc.,
| 510(k) | Device | Decision |
|---|---|---|
| K103037 | Ind Urinary Tract Infection (Uti) Test StripsNGJ · Traditional | 04/17/2012SE |
| K063390 | Urine Chemistry Analyzer UR-50JIL · Traditional | 03/01/2007SE |
| K060810 | One Step Drug Test - Amp/Met/Mor/Thc/CocDKZ · Traditional | 08/07/2006SE |
| K052694 | One Step HCG Pregnancy Test - 2000 Miu/Ml, Model 100 Series.JHI · Traditional | 12/16/2005SE |
| K052662 | One Step FSH Menopausal TestCGJ · Traditional | 11/30/2005SE |
| K050741 | Ind One Step HCG Pregnancy Test - Cassette FormatJHI · Traditional | 05/16/2005SE |
| K023638 | Cassette/Urine HCGLCX · Traditional | 01/03/2003SE |
Questions and answers
When was Ind One Step Fecal Occult Blood Test Model 440-10 cleared by the FDA?
Ind One Step Fecal Occult Blood Test Model 440-10 (K100031) received a 510(k) decision of Substantially Equivalent on July 19, 2010, 194 days after the submission was received.
What is the product code of K100031?
The FDA product code is KHE – Reagent, Occult Blood, a Class II (moderate risk) device regulated under 21 CFR 864.6550.