Giardia Fecal Antigen Detection Lateral Flow Kit, Model Gl-Lf
FDA 510(k) K081064 · Ivd Research, Inc.
510(k) numberK081064
Submission
- Device name
- Giardia Fecal Antigen Detection Lateral Flow Kit, Model Gl-Lf
- Applicant
- Ivd Research, Inc.
Tucson, AZ, US - Received
- April 14, 2008
- Decision date
- January 14, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHI – Giardia Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3220
- Specialty
- Microbiology
Other 510(k)s with product code MHI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120001 | Unigold GiardiaMHI · Traditional | Trinity Biotech | 03/01/2013SE |
| K103673 | Giardia/ Cryptosporidium Quik ChekMHI · Traditional | Techlab Inc., Corporate Research Center | 08/18/2011SE |
| K031942 | Xpect Giardia Lateral Flow Assay, Model 2450020MHI · Traditional | Remel, Inc. | 11/18/2003SE |
| K031834 | Xpect Giardia/Cryptosporidium Lateral Flow AssayMHI · Traditional | Remel, Inc. | 11/10/2003SE |
| K033274 | Giardia IIMHI · Special | Techlab, Inc. | 11/04/2003SE |
| K024113 | IVD Crypto/Giardia DfaMHI · Traditional | Ivd Research, Inc. | 03/05/2003SE |
| K020583 | IVD Giardia Antigen Detection Assay Model GL-96MHI · Traditional | Ivd Research, Inc. | 09/17/2002SE |
| K983399 | Giardia/Cryptosporidium Combo Rapid AssayMHI · Traditional | Genzyme Diagnostics | 01/11/1999SE |
| K982711 | Premier GiardiaMHI · Traditional | Meridian Diagnostics, Inc. | 11/25/1998SE |
| K982245 | Triage,Parasite Panel, Triage Cryptosporidium and Entamoeba Histolytica, Triage…MHI · Traditional | Biosite Incorporated | 10/06/1998SE |
More from Biosite Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K032897 | C. Difficile Toxin a + B Fecal Antigen Detection Microwell Elisa Kit Model; CDIFF-96LLH · Traditional | 05/27/2004SE |
| K031059 | IVD Cryptosporidium Antigen Detection Assay, Model CP-96MHJ · Traditional | 07/10/2003SE |
| K024113 | IVD Crypto/Giardia DfaMHI · Traditional | 03/05/2003SE |
| K020583 | IVD Giardia Antigen Detection Assay Model GL-96MHI · Traditional | 09/17/2002SE |
Questions and answers
When was Giardia Fecal Antigen Detection Lateral Flow Kit, Model Gl-Lf cleared by the FDA?
Giardia Fecal Antigen Detection Lateral Flow Kit, Model Gl-Lf (K081064) received a 510(k) decision of Substantially Equivalent on January 14, 2009, 275 days after the submission was received.
What is the product code of K081064?
The FDA product code is MHI – Giardia Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3220.