The following data is part of a premarket notification filed by Ameritek, Inc. with the FDA for Best Pregnancy Test.
| Device ID | K953606 |
| 510k Number | K953606 |
| Device Name: | BEST PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | AMERITEK, INC. 7030 35TH AVE., N.E. Seattle, WA 98115 |
| Contact | H C Yee |
| Correspondent | H C Yee AMERITEK, INC. 7030 35TH AVE., N.E. Seattle, WA 98115 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-02 |
| Decision Date | 1996-03-22 |
| Summary: | summary |