Prospect/Giardia
FDA 510(k) K874849 · Alexon Biomedical, Inc.
510(k) numberK874849
Submission
- Device name
- Prospect/Giardia
- Applicant
- Alexon Biomedical, Inc.
Glen Ellyn, IL, US - Received
- November 25, 1987
- Decision date
- January 5, 1988
- 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 |
| 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 |
|---|---|---|
| K964864 | Prospect II Clostridium Diffillie Toxin a Microplate AssayLLH · Traditional | 02/04/1997SE |
| K955157 | Prospect Giardia/Cryptosporidium Microplate AssayMHI · Traditional | 02/09/1996SE |
| K936191 | Prospect Cryptosporidium Rapid AssayMHJ · Traditional | 11/17/1994SE |
| K933997 | Prospect Entamoeba Histolytica Microplate AssayGMD · Traditional | 11/22/1993SE |
Questions and answers
When was Prospect/Giardia cleared by the FDA?
Prospect/Giardia (K874849) received a 510(k) decision of Substantially Equivalent on January 5, 1988, 41 days after the submission was received.
What is the product code of K874849?
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.