The following data is part of a premarket notification filed by Bionike Laboratories, Inc. with the FDA for Bionike A/q Pregnancy Test.
| Device ID | K954901 |
| 510k Number | K954901 |
| Device Name: | BIONIKE A/Q PREGNANCY TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | BIONIKE LABORATORIES, INC. 1206 SESAME DR. Sunnyvale, CA 94087 |
| Contact | Janis Freestone |
| Correspondent | Janis Freestone BIONIKE LABORATORIES, INC. 1206 SESAME DR. Sunnyvale, CA 94087 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-25 |
| Decision Date | 1995-12-11 |