Amebiasis Microassay
FDA 510(k) K863811 · Diamedix Corp.
510(k) numberK863811
Submission
- Device name
- Amebiasis Microassay
- Applicant
- Diamedix Corp.
Miami, FL, US - Received
- September 30, 1986
- Decision date
- October 9, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHW – Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3220
- Specialty
- Microbiology
Other 510(k)s with product code KHW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170728 | E. Histolytica Quik ChekKHW · Traditional | Techlab, Inc. | 06/07/2017SE |
| K994101 | E. Histolytica IIKHW · Special | Techlab, Inc. | 12/21/1999SE |
| K955895 | E. Histolytica TestKHW · Traditional | Techlab, Inc. | 08/30/1996SE |
| K954996 | Trend Amebiasis (E.Histolytica) Serological Elisa Test SystemKHW · Traditional | Trend Scientific, Inc. | 08/08/1996SE |
| K944791 | Entamoeba TestKHW · Traditional | Techlab, Inc. | 03/09/1995SE |
| K900604 | Direct Fluorescent Antibody Reagent for GiardiaKHW · Traditional | Biovir Laboratories, Inc. | 07/26/1990SE |
| K890774 | Giardeia(Tm)KHW · Traditional | Antibodies, Inc. | 04/04/1989SE |
| K890003 | Giardia Stool Antigen Test KitKHW · Traditional | Lmd Laboratories | 03/14/1989SE |
| K874849 | Prospect/GiardiaKHW · Traditional | Alexon Biomedical, Inc. | 01/05/1988SE |
| K870318 | Amebiasis Elisa Test KitKHW · Traditional | Lmd Laboratories | 08/11/1987SE |
More from Lmd Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K093101 | Mago 4SLFX · Traditional | 01/21/2011SE |
| K021394 | Diamedix Is-Rheumatoid Factor Test SystemDHR · Traditional | 07/09/2002SE |
| K013956 | Diamedix IS-ANTI-B2 Glycoprotein I ScreenMSV · Traditional | 01/08/2002SE |
| K013628 | Diamedix IS-ANTI-B2 Glycoprotein I Igg/Igm Test SystemMSV · Traditional | 12/21/2001SE |
| K012450 | Diamedix Is-Anti-Cardiolipin Iga Test SystemMID · Traditional | 10/26/2001SE |
| K012449 | Diamedix Is-Anti-Cardiolipin Igg/Igm Test SystemMID · Traditional | 10/26/2001SE |
| K012797 | Diamedix Is-Anti-Gliadin Iga Test SystemMST · Traditional | 09/28/2001SE |
| K012795 | Diamedix Is-Anti-Gliadin Igg Test SystemMST · Traditional | 09/28/2001SE |
| K012053 | Diamedix Is-Anti-Cardiolipin Screen Test SystemMID · Traditional | 08/20/2001SE |
| K002262 | Diamedix Is-Hsv 1&2 Igm Test SystemLGC · Traditional | 11/28/2000SE |
Questions and answers
When was Amebiasis Microassay cleared by the FDA?
Amebiasis Microassay (K863811) received a 510(k) decision of Substantially Equivalent on October 9, 1986, 9 days after the submission was received.
What is the product code of K863811?
The FDA product code is KHW – Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3220.