E. Histolytica Test
FDA 510(k) K955895 · Techlab, Inc.
510(k) numberK955895
Submission
- Device name
- E. Histolytica Test
- Applicant
- Techlab, Inc.
Blacksburg, VA, US - Received
- December 26, 1995
- Decision date
- August 30, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K863811 | Amebiasis MicroassayKHW · Traditional | Diamedix Corp. | 10/09/1986SE |
More from Diamedix Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K191456 | Campylobacter Quik ChekLQP · Special | 06/20/2019SE |
| K191442 | Campylobacter ChekLQP · Special | 06/20/2019SE |
| K181400 | H. Pylori ChekLYR · Traditional | 08/21/2018SE |
| K181379 | H. Pylori Quik ChekLYR · Traditional | 08/21/2018SE |
| K173219 | Campylobacter ChekLQP · Traditional | 01/22/2018SE |
| K173217 | Campylobacter Quik ChekLQP · Traditional | 01/22/2018SE |
| K171078 | Tri-Combo Parasite ScreenMHJ · Traditional | 07/10/2017SE |
| K170728 | E. Histolytica Quik ChekKHW · Traditional | 06/07/2017SE |
| K082499 | C. Diff Quik Chek CompleteLLH · Traditional | 03/26/2009SE |
| K053572 | C. Diff Quik ChekMCB · Traditional | 04/26/2006SE |
Questions and answers
When was E. Histolytica Test cleared by the FDA?
E. Histolytica Test (K955895) received a 510(k) decision of Substantially Equivalent on August 30, 1996, 248 days after the submission was received.
What is the product code of K955895?
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.