Xpect Cryptosporidium Lateral Flow Assay, Model 2451020
FDA 510(k) K031965 · Remel, Inc.
510(k) numberK031965
Submission
- Device name
- Xpect Cryptosporidium Lateral Flow Assay, Model 2451020
- Applicant
- Remel, Inc.
Ramsey, MN, US - Received
- June 26, 2003
- Decision date
- November 14, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHJ – Cryptosporidium Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3220
- Specialty
- Microbiology
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| K171078 | Tri-Combo Parasite ScreenMHJ · Traditional | Techlab, Inc. | 07/10/2017SE |
| K121565 | Uni-Gold CryptosporidiumMHJ · Traditional | Trinity Biotech | 02/08/2013SE |
| K051929 | Giardia/Cryptosporidium ChekMHJ · Traditional | Techlab, Inc. | 11/17/2005SE |
| K052932 | Cryptosporidium IIMHJ · Special | Techlab, Inc. | 11/04/2005SE |
| K031059 | IVD Cryptosporidium Antigen Detection Assay, Model CP-96MHJ · Traditional | Ivd Research, Inc. | 07/10/2003SE |
| K982764 | Premier CryptosporidiumMHJ · Traditional | Meridian Diagnostics, Inc. | 12/03/1998SE |
| K982709 | Modification to Prospect Cryptosporidium Microtiter AssayMHJ · Special | Alexon - Trend, Inc. | 09/03/1998SE |
| K980354 | Cryptosporidium TestMHJ · Traditional | Techlab, Inc. | 05/18/1998SE |
| K955852 | Crypto-Cel If TestMHJ · Traditional | Techlab, Inc. | 08/05/1996SE |
| K955755 | Trend Cryptosporidium Detection Test SystemsMHJ · Traditional | Trend Scientific, Inc. | 07/11/1996SE |
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| K092407 | Remel Spectra MrsaJSO · Traditional | 10/08/2010SE |
| K072827 | Rpmi 1640 Agar W/Mops and 2% GlucoseMJE · Traditional | 11/26/2007SE |
| K041951 | Xpect Clostridium Difficile Toxin A/BLLH · Traditional | 11/15/2004SE |
| K033479 | Prospect Clostridium Difficile Toxin A/B Microplate AssayLLH · Traditional | 02/26/2004SE |
| K031942 | Xpect Giardia Lateral Flow Assay, Model 2450020MHI · Traditional | 11/18/2003SE |
| K031834 | Xpect Giardia/Cryptosporidium Lateral Flow AssayMHI · Traditional | 11/10/2003SE |
| K031565 | Xpect Influenza A/BPSZ · Traditional | 07/17/2003SE |
| K013711 | Bacti-Swab DryLIO · Traditional | 11/26/2001SE |
Questions and answers
When was Xpect Cryptosporidium Lateral Flow Assay, Model 2451020 cleared by the FDA?
Xpect Cryptosporidium Lateral Flow Assay, Model 2451020 (K031965) received a 510(k) decision of Substantially Equivalent on November 14, 2003, 141 days after the submission was received.
What is the product code of K031965?
The FDA product code is MHJ – Cryptosporidium Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3220.