The following data is part of a premarket notification filed by Ivd Research, Inc. with the FDA for Ivd Giardia Antigen Detection Assay Model Gl-96.
| Device ID | K020583 |
| 510k Number | K020583 |
| Device Name: | IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 |
| Classification | Giardia Spp. |
| Applicant | IVD RESEARCH, INC. 5909 SEA LION PLACE, SUITE D Carlsbad, CA 92008 |
| Contact | Dave Lambillotte |
| Correspondent | Dave Lambillotte IVD RESEARCH, INC. 5909 SEA LION PLACE, SUITE D Carlsbad, CA 92008 |
| Product Code | MHI |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-21 |
| Decision Date | 2002-09-17 |