Trend Giardia Direct Detection RS Test System
FDA 510(k) K953284 · Trend Scientific, Inc.
510(k) numberK953284
Submission
- Device name
- Trend Giardia Direct Detection RS Test System
- Applicant
- Trend Scientific, Inc.
New Brighton, MN, US - Received
- July 13, 1995
- Decision date
- October 6, 1995
- 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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|---|---|---|---|
| K120001 | Unigold GiardiaMHI · Traditional | Trinity Biotech | 03/01/2013SE |
| 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 |
More from Meridian Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954996 | Trend Amebiasis (E.Histolytica) Serological Elisa Test SystemKHW · Traditional | 08/08/1996SE |
| K955755 | Trend Cryptosporidium Detection Test SystemsMHJ · Traditional | 07/11/1996SE |
| K952467 | Trend Giardia Lamblia Direct Detection System (Modified Kit)MHI · Traditional | 11/20/1995SE |
| K862914 | Fekal Check Parasitology Control SlideJTR · Traditional | 09/16/1986SE |
| K830769 | Fekal Con-Trate SystemKLI · Traditional | 04/05/1983SE |
Questions and answers
When was Trend Giardia Direct Detection RS Test System cleared by the FDA?
Trend Giardia Direct Detection RS Test System (K953284) received a 510(k) decision of Substantially Equivalent on October 6, 1995, 85 days after the submission was received.
What is the product code of K953284?
The FDA product code is MHI – Giardia Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3220.