The following data is part of a premarket notification filed by Ameritek Usa, Inc. with the FDA for Dbest Hcg Panel Test Kit.
| Device ID | K061257 |
| 510k Number | K061257 |
| Device Name: | DBEST HCG PANEL TEST KIT |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | AMERITEK USA, INC. 125 130 ST. SE, #200 Everett, WA 98208 |
| Contact | K C Yee |
| Correspondent | K C Yee AMERITEK USA, INC. 125 130 ST. SE, #200 Everett, WA 98208 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-04 |
| Decision Date | 2007-05-04 |