The following data is part of a premarket notification filed by Ameritek, Inc. with the FDA for Dbest One-step Hcg Serum/urine Test.
| Device ID | K973957 |
| 510k Number | K973957 |
| Device Name: | DBEST ONE-STEP HCG SERUM/URINE TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| 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 | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-16 |
| Decision Date | 1997-12-17 |