Cryptosporidium Spp.
FDA product code MHJ · Class II (moderate risk) · 21 CFR 866.3220 · Microbiology
15510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K955345 | LMD Cryptosporidium Antigen DetectionMHJ · Traditional | Lmd Laboratories | 06/07/1996SE |
| K936191 | Prospect Cryptosporidium Rapid AssayMHJ · Traditional | Alexon Biomedical, Inc. | 11/17/1994SE |
| K912242 | Prospect(Tm/CryptosporidiumMHJ · Traditional | Alexon, Inc. | 03/23/1992SE |
| K905598 | Cryptosporidium Antigen DetectionMHJ · Traditional | Lmd Laboratories | 09/05/1991SE |