IVD Cryptosporidium Antigen Detection Assay, Model CP-96
FDA 510(k) K031059 · Ivd Research, Inc.
510(k) numberK031059
Submission
- Device name
- IVD Cryptosporidium Antigen Detection Assay, Model CP-96
- Applicant
- Ivd Research, Inc.
Carlsbad, CA, US - Received
- March 28, 2003
- Decision date
- July 10, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- MHJ – Cryptosporidium Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3220
- Specialty
- Microbiology
Other 510(k)s with product code MHJ
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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 |
| K031965 | Xpect Cryptosporidium Lateral Flow Assay, Model 2451020MHJ · Traditional | Remel, Inc. | 11/14/2003SE |
| 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 |
More from Trend Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K081064 | Giardia Fecal Antigen Detection Lateral Flow Kit, Model Gl-LfMHI · Traditional | 01/14/2009SE |
| K032897 | C. Difficile Toxin a + B Fecal Antigen Detection Microwell Elisa Kit Model; CDIFF-96LLH · Traditional | 05/27/2004SE |
| K024113 | IVD Crypto/Giardia DfaMHI · Traditional | 03/05/2003SE |
| K020583 | IVD Giardia Antigen Detection Assay Model GL-96MHI · Traditional | 09/17/2002SE |
Questions and answers
When was IVD Cryptosporidium Antigen Detection Assay, Model CP-96 cleared by the FDA?
IVD Cryptosporidium Antigen Detection Assay, Model CP-96 (K031059) received a 510(k) decision of Substantially Equivalent on July 10, 2003, 104 days after the submission was received.
What is the product code of K031059?
The FDA product code is MHJ – Cryptosporidium Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3220.