Crypto/Giardia-Cel If Test
FDA 510(k) K955897 · Techlab, Inc.
510(k) numberK955897
Submission
- Device name
- Crypto/Giardia-Cel If Test
- Applicant
- Techlab, Inc.
Blacksburg, VA, US - Received
- December 26, 1995
- Decision date
- August 5, 1996
- 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 |
| 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 |
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|---|---|---|
| K191456 | Campylobacter Quik ChekLQP · Special | 06/20/2019SE |
| K191442 | Campylobacter ChekLQP · Special | 06/20/2019SE |
| K181400 | H. Pylori ChekLYR · Traditional | 08/21/2018SE |
| K181379 | H. Pylori Quik ChekLYR · Traditional | 08/21/2018SE |
| K173219 | Campylobacter ChekLQP · Traditional | 01/22/2018SE |
| K173217 | Campylobacter Quik ChekLQP · Traditional | 01/22/2018SE |
| K171078 | Tri-Combo Parasite ScreenMHJ · Traditional | 07/10/2017SE |
| K170728 | E. Histolytica Quik ChekKHW · Traditional | 06/07/2017SE |
| K082499 | C. Diff Quik Chek CompleteLLH · Traditional | 03/26/2009SE |
| K053572 | C. Diff Quik ChekMCB · Traditional | 04/26/2006SE |
Questions and answers
When was Crypto/Giardia-Cel If Test cleared by the FDA?
Crypto/Giardia-Cel If Test (K955897) received a 510(k) decision of Substantially Equivalent on August 5, 1996, 223 days after the submission was received.
What is the product code of K955897?
The FDA product code is MHI – Giardia Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3220.