The following data is part of a premarket notification filed by Epitope Diagnostics, Inc. with the FDA for Care Fecal Occult Blood Test, Model Kt313.
| Device ID | K051806 |
| 510k Number | K051806 |
| Device Name: | CARE FECAL OCCULT BLOOD TEST, MODEL KT313 |
| Classification | Reagent, Occult Blood |
| Applicant | EPITOPE DIAGNOSTICS, INC. 7955 DUNBROOK RD., SUITE B San Diego, CA 92126 |
| Contact | Ping Gao |
| Correspondent | Ping Gao EPITOPE DIAGNOSTICS, INC. 7955 DUNBROOK RD., SUITE B San Diego, CA 92126 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-05 |
| Decision Date | 2005-10-03 |