The following data is part of a premarket notification filed by Ivd Research, Inc. with the FDA for Ivd Cryptosporidium Antigen Detection Assay, Model Cp-96.
| Device ID | K031059 |
| 510k Number | K031059 |
| Device Name: | IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 |
| Classification | Cryptosporidium Spp. |
| Applicant | IVD RESEARCH, INC. 5909 SEA LION PLACE, SUITE D Carlsbad, CA 92008 |
| Contact | Dave Lambillotte |
| Correspondent | Alfredo J Quattrone CALIFORNIA DEPARTMENT OF HEALTH SERVICES P.O. BOX 942732 (MS-357) Sacramento, CA 94234 -7320 |
| Product Code | MHJ |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-03-28 |
| Decision Date | 2003-07-10 |
| Summary: | summary |