Giardeia(Tm)
FDA 510(k) K890774 · Antibodies, Inc.
510(k) numberK890774
Submission
- Device name
- Giardeia(Tm)
- Applicant
- Antibodies, Inc.
Davis, CA, US - Received
- February 15, 1989
- Decision date
- April 4, 1989
- 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 |
| 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 |
|---|---|---|
| K843590 | Detect-A-StrepGTZ · Traditional | 10/30/1984SE |
| K822892 | Cortisol Ria KitCGR · Traditional | 11/01/1982SE |
| K812749 | Ultra-DigLCS · Traditional | 10/19/1981SE |
| K812314 | Crithidna Anti-Dna Test KitDHN · Traditional | 09/01/1981SE |
| K802877 | Amikacin Ria KitKLQ · Traditional | 12/19/1980SE |
| K800743 | Tobramycin Ria KitKLB · Traditional | 04/16/1980SE |
| K791217 | TSH Ria KitJLW · Traditional | 09/04/1979SE |
| K781656 | Nephelrate Antiserums, IggCFN · Traditional | 11/08/1978SE |
| K781655 | Nephelrate Antiserums 1GACFN · Traditional | 11/08/1978SE |
| K781654 | Nephelrate Antiperums LGMCFN · Traditional | 11/08/1978SE |
Questions and answers
When was Giardeia(Tm) cleared by the FDA?
Giardeia(Tm) (K890774) received a 510(k) decision of Substantially Equivalent on April 4, 1989, 48 days after the submission was received.
What is the product code of K890774?
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.