Ease-A-Cult
FDA 510(k) K002756 · Diagnostica, Inc.
510(k) numberK002756
Submission
- Device name
- Ease-A-Cult
- Applicant
- Diagnostica, Inc.
Crofton, MD, US - Received
- September 5, 2000
- Decision date
- February 23, 2001
- 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.,
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| K823348 | H. Influenza B Antisera for CieGRP · Traditional | 12/28/1982SE |
| K812434 | Diagnostic Kits & Kit ComponentsLHT · Traditional | 09/23/1981SE |
| K800398 | Paracontrol Abnormal Immunoglobulin ContDEW · Traditional | 03/12/1980SE |
| K791284 | Anti-Human Kappa SerumDFH · Traditional | 11/27/1979SE |
| K791283 | Anti-Human Lambda SerumDEH · Traditional | 11/27/1979SE |
| K791281 | Anti-Human Igg SerumDEW · Traditional | 11/27/1979SE |
| K791285 | Anti-Human GlobulinsDEW · Traditional | 10/17/1979SE |
| K791282 | Anti-Human SerumDGQ · Traditional | 10/17/1979SE |
| K790672 | Aspergillus Fumigatus, Aspergillus FlavuJWT · Traditional | 05/31/1979SE |
| K790671 | Dermatophytin OJXB · Traditional | 05/31/1979SE |
Questions and answers
When was Ease-A-Cult cleared by the FDA?
Ease-A-Cult (K002756) received a 510(k) decision of Substantially Equivalent on February 23, 2001, 171 days after the submission was received.
What is the product code of K002756?
The FDA product code is KHE – Reagent, Occult Blood, a Class II (moderate risk) device regulated under 21 CFR 864.6550.