The following data is part of a premarket notification filed by Wyntek Diagnostics, Inc. with the FDA for Osom Pregnancy Test.
| Device ID | K954178 |
| 510k Number | K954178 |
| Device Name: | OSOM PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | WYNTEK DIAGNOSTICS, INC. 6146 NANCY RIDGE DR., SUITE 101 San Diego, CA 92121 |
| Contact | Shu-ching Cheng |
| Correspondent | Shu-ching Cheng WYNTEK DIAGNOSTICS, INC. 6146 NANCY RIDGE DR., SUITE 101 San Diego, CA 92121 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-05 |
| Decision Date | 1995-10-23 |