Hillcrest Amebiasis Iha Test
FDA 510(k) K853448 · Hillcrest Biologicals
510(k) numberK853448
Submission
- Device name
- Hillcrest Amebiasis Iha Test
- Applicant
- Hillcrest Biologicals
Cypress, CA, US - Received
- August 16, 1985
- Decision date
- August 28, 1985
- 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 |
|---|---|---|
| K913618 | Arbovirus Igm Ifa TestGQC · Traditional | 12/03/1992SE |
| K913617 | Arbovirus Igg Ifa TestGQC · Traditional | 12/03/1992SE |
| K922374 | Q Fever Igm Ifa TestGPJ · Traditional | 10/21/1992SE |
| K913906 | Q Fever Igg Ifa TestGPJ · Traditional | 10/21/1992SE |
| K900206 | Lyme Disease Igm ElisaLSR · Traditional | 06/28/1991SE |
| K896594 | Ebv Vca Antibody (Igm)LJN · Traditional | 01/16/1990SE |
| K884829 | Ebv Early Antigen (R+D)JRY · Traditional | 04/12/1989SE |
| K883767 | Lyme Disease Ifa (Igm)LSR · Traditional | 03/15/1989SE |
| K884591 | Ebv-Vca Antibody (Igg)GNP · Traditional | 01/24/1989SE |
| K883487 | Lyme Disease Ifa (Igg)LSR · Traditional | 12/13/1988SE |
Questions and answers
When was Hillcrest Amebiasis Iha Test cleared by the FDA?
Hillcrest Amebiasis Iha Test (K853448) received a 510(k) decision of Substantially Equivalent on August 28, 1985, 12 days after the submission was received.
What is the product code of K853448?
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.