The following data is part of a premarket notification filed by Ameritek Usa, Inc. with the FDA for Dbest One Step Occult Blood Test Kits.
| Device ID | K071242 |
| 510k Number | K071242 |
| Device Name: | DBEST ONE STEP OCCULT BLOOD TEST KITS |
| Classification | Reagent, Occult Blood |
| Applicant | AMERITEK USA, INC. 125 130TH ST. SE Everett, WA 98208 |
| Contact | K.c. Yee |
| Correspondent | K.c. Yee AMERITEK USA, INC. 125 130TH ST. SE Everett, WA 98208 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-03 |
| Decision Date | 2008-03-06 |