Hemo Fec
FDA 510(k) K780214 · Boehringer Mannheim Corp.
510(k) numberK780214
Submission
- Device name
- Hemo Fec
- Applicant
- Boehringer Mannheim Corp.
Mchenry, IL, US - Received
- February 8, 1978
- Decision date
- May 3, 1978
- 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 |
|---|---|---|
| K984326 | Elecys Ige AssayJHR · Traditional | 02/08/1999SE |
| K983047 | Accu-Chek HQ SystemLFR · Traditional | 02/05/1999SE |
| K984419 | Elecsys Ige CalcheckJJY · Traditional | 02/02/1999SE |
| K984425 | Modification of Preciset Serum Proteins CalibratorJIX · Traditional | 01/20/1999SE |
| K984372 | Elecsys Calcheck Troponin TJJY · Traditional | 12/14/1998SE |
| K984105 | Elecsys Troponin T Stat TestMMI · Traditional | 12/08/1998SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
| K983185 | Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional | 11/12/1998SE |
| K983510 | Chemstrip 101 Urine AnalyzerKQO · Special | 10/27/1998SE |
Questions and answers
When was Hemo Fec cleared by the FDA?
Hemo Fec (K780214) received a 510(k) decision of Substantially Equivalent on May 3, 1978, 84 days after the submission was received.
What is the product code of K780214?
The FDA product code is KHE – Reagent, Occult Blood, a Class II (moderate risk) device regulated under 21 CFR 864.6550.