The following data is part of a premarket notification filed by Ivd Research, Inc. with the FDA for Giardia Fecal Antigen Detection Lateral Flow Kit, Model Gl-lf.
| Device ID | K081064 |
| 510k Number | K081064 |
| Device Name: | GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF |
| Classification | Giardia Spp. |
| Applicant | IVD RESEARCH, INC. 5470 E. EDWIN RD. Tucson, AZ 85739 |
| Contact | Michael Wienholt |
| Correspondent | Michael Wienholt IVD RESEARCH, INC. 5470 E. EDWIN RD. Tucson, AZ 85739 |
| Product Code | MHI |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-14 |
| Decision Date | 2009-01-14 |
| Summary: | summary |