The following data is part of a premarket notification filed by Ameritek, Inc. with the FDA for Dbest One-step Ovulation Test.
| Device ID | K974508 |
| 510k Number | K974508 |
| Device Name: | DBEST ONE-STEP OVULATION TEST |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | AMERITEK, INC. 7030 35TH AVE., N.E. Seattle, WA 98115 |
| Contact | Kuo Chiang Yee |
| Correspondent | Kuo Chiang Yee AMERITEK, INC. 7030 35TH AVE., N.E. Seattle, WA 98115 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-01 |
| Decision Date | 1998-02-02 |