Unigold Giardia
FDA 510(k) K120001 · Trinity Biotech
510(k) numberK120001
Submission
- Device name
- Unigold Giardia
- Applicant
- Trinity Biotech
Carlsbad, CA, US - Received
- January 3, 2012
- Decision date
- March 1, 2013
- 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
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K103673 | Giardia/ Cryptosporidium Quik ChekMHI · Traditional | Techlab Inc., Corporate Research Center | 08/18/2011SE |
| K081064 | Giardia Fecal Antigen Detection Lateral Flow Kit, Model Gl-LfMHI · Traditional | Ivd Research, Inc. | 01/14/2009SE |
| 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 |
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Questions and answers
When was Unigold Giardia cleared by the FDA?
Unigold Giardia (K120001) received a 510(k) decision of Substantially Equivalent on March 1, 2013, 423 days after the submission was received.
What is the product code of K120001?
The FDA product code is MHI – Giardia Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3220.