The following data is part of a premarket notification filed by Ameritek, Inc. with the FDA for Dbest Occult Blood Test Kit.
| Device ID | K984269 |
| 510k Number | K984269 |
| Device Name: | DBEST OCCULT BLOOD TEST KIT |
| Classification | Reagent, Occult Blood |
| Applicant | AMERITEK, INC. 7030 35TH AVE., N.E. Seattle, WA 98115 |
| Contact | K C Yee |
| Correspondent | K C Yee AMERITEK, INC. 7030 35TH AVE., N.E. Seattle, WA 98115 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-22 |
| Decision Date | 1999-05-11 |