Accu-Cult Fecal Occult Blood Test
FDA 510(k) K840904 · Applied Medical Devices, Inc.
510(k) numberK840904
Submission
- Device name
- Accu-Cult Fecal Occult Blood Test
- Applicant
- Applied Medical Devices, Inc.
Mchenry, IL, US - Received
- February 28, 1984
- Decision date
- August 16, 1984
- 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 |
|---|---|---|
| K843885 | Percutaneous Aspiration Biopsy Tray · Traditional | 12/19/1984SE |
| K843884 | General Utility Tray System · Traditional | 12/13/1984SE |
| K843883 | Sterile Percutaneous Transhepatic Cholan · Traditional | 12/13/1984SE |
| K842591 | Ultrasound Probe Covers-SterileIYO · Traditional | 07/23/1984SE |
| K833720 | Transthoracic/Transabdominal-TrayGDM · Traditional | 05/30/1984SE |
| K840334 | Chemonucleolysis/Discography TrayFMI · Traditional | 04/13/1984SE |
| K833438 | Prepacell-Sterile-Bone Marrow AspirKDD · Traditional | 02/09/1984SE |
| K833719 | Prepacell Thin Needle Aspiration TrayKOD · Traditional | 01/25/1984SE |
| K802406 | Cytotran I Bone Marrow Aspiration SystemFMF · Traditional | 01/15/1981SE |
| K791660 | Prepacell-Bone Marrow SamplerFMF · Traditional | 09/12/1979SE |
Questions and answers
When was Accu-Cult Fecal Occult Blood Test cleared by the FDA?
Accu-Cult Fecal Occult Blood Test (K840904) received a 510(k) decision of Substantially Equivalent on August 16, 1984, 170 days after the submission was received.
What is the product code of K840904?
The FDA product code is KHE – Reagent, Occult Blood, a Class II (moderate risk) device regulated under 21 CFR 864.6550.