The following data is part of a premarket notification filed by Yd Diagnostics Corp. with the FDA for Occultech Fecal Occult Blood Rapid Test.
| Device ID | K060953 |
| 510k Number | K060953 |
| Device Name: | OCCULTECH FECAL OCCULT BLOOD RAPID TEST |
| Classification | Reagent, Occult Blood |
| Applicant | YD DIAGNOSTICS CORP. 4304 EVERGREEN LANE SUITE 101 Annandale, VA 22003 |
| Contact | Dusic Kwak |
| Correspondent | Dusic Kwak YD DIAGNOSTICS CORP. 4304 EVERGREEN LANE SUITE 101 Annandale, VA 22003 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-06 |
| Decision Date | 2006-09-18 |
| Summary: | summary |