Campylobacter Quik Chek
FDA 510(k) K173217 · Techlab, Inc.
510(k) numberK173217
Submission
- Device name
- Campylobacter Quik Chek
- Applicant
- Techlab, Inc.
Blacksburg, VA, US - Received
- October 3, 2017
- Decision date
- January 22, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LQP – Campylobacter Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3110
- Specialty
- Microbiology
Other 510(k)s with product code LQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210976 | Curian CampyLQP · Traditional | Meridian Bioscience, Inc. | 12/23/2021SE |
| K211342 | Sofia 2 Campylobacter FIALQP · Traditional | Quidel Corporation | 11/23/2021SE |
| K191456 | Campylobacter Quik ChekLQP · Special | Techlab, Inc. | 06/20/2019SE |
| K191442 | Campylobacter ChekLQP · Special | Techlab, Inc. | 06/20/2019SE |
| K173219 | Campylobacter ChekLQP · Traditional | Techlab, Inc. | 01/22/2018SE |
| K090700 | Immunocard Stat Campy, Model 751530LQP · Traditional | Meridian Bioscience, Inc. | 05/28/2009SE |
| K083464 | Premier Campy, Model 618096LQP · Traditional | Meridian Bioscience, Inc. | 01/30/2009SE |
| K982315 | Prospect Campylobacter Microplate AssayLQP · Traditional | Alexon - Trend, Inc. | 11/18/1998SE |
| K880389 | Meritec(Tm)-Campy (JCL)LQP · Traditional | Meridian Diagnostics, Inc. | 04/12/1988SE |
| K864027 | BBL Campyslide(Tm) TestLQP · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/11/1986SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| 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 |
| K051927 | Techlab Asca-ChekNBT · Traditional | 04/06/2006SE |
Questions and answers
When was Campylobacter Quik Chek cleared by the FDA?
Campylobacter Quik Chek (K173217) received a 510(k) decision of Substantially Equivalent on January 22, 2018, 111 days after the submission was received.
What is the product code of K173217?
The FDA product code is LQP – Campylobacter Spp., a Class I (low risk) device regulated under 21 CFR 866.3110.