Ez-Detect Visual Color Test for Blood in Stool
FDA 510(k) K850431 · Nms Pharmaceuticals, Inc.
510(k) numberK850431
Submission
- Device name
- Ez-Detect Visual Color Test for Blood in Stool
- Applicant
- Nms Pharmaceuticals, Inc.
Newport Beach, CA, US - Received
- February 4, 1985
- Decision date
- June 17, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K861202 | Tru-Level Control Immunoassay ControlsJJY · Traditional | 01/09/1987SE |
| K854236 | Histamine Ria Test for Histamine Biological FluidsIAF · Traditional | 10/10/1986SN |
| K860828 | Foretel, Color Ovulation TestCEP · Traditional | 08/04/1986SE |
| K853925 | Quantitative Determination of HCG in Serum-ElisaJHI · Traditional | 12/02/1985SE |
| K851445 | Color Ovulation TestCEP · Traditional | 07/29/1985SE |
| K850786 | Total Hige Enzyme ImmunoassayDGC · Traditional | 04/12/1985SE |
| K850787 | Solid Phase Free Estriol Enzyme ImmunoassayCGI · Traditional | 03/26/1985SE |
| K842499 | NMS 1043 Enzyme Immunoassay KitJHI · Traditional | 09/14/1984SE |
Questions and answers
When was Ez-Detect Visual Color Test for Blood in Stool cleared by the FDA?
Ez-Detect Visual Color Test for Blood in Stool (K850431) received a 510(k) decision of Substantially Equivalent on June 17, 1985, 133 days after the submission was received.
What is the product code of K850431?
The FDA product code is KHE – Reagent, Occult Blood, a Class II (moderate risk) device regulated under 21 CFR 864.6550.