The following data is part of a premarket notification filed by Bionike, Inc. with the FDA for Advanced Quality Pregnancy Test.
| Device ID | K970008 |
| 510k Number | K970008 |
| Device Name: | ADVANCED QUALITY PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | BIONIKE, INC. 1015 GRANDVIEW DR. South San Francisco, CA 94080 -4910 |
| Contact | Janis Freestone |
| Correspondent | Janis Freestone BIONIKE, INC. 1015 GRANDVIEW DR. South San Francisco, CA 94080 -4910 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-02 |
| Decision Date | 1997-02-18 |