The following data is part of a premarket notification filed by Wyntek Diagnostics, Inc. with the FDA for Osom Classic Hcg-urine Test (115).
| Device ID | K965227 |
| 510k Number | K965227 |
| Device Name: | OSOM CLASSIC HCG-URINE TEST (115) |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | WYNTEK DIAGNOSTICS, INC. 6145 NANCY RIDGE DR. SUITE 101 San Diego, CA 92121 |
| Contact | Shu-ching Cheng |
| Correspondent | Shu-ching Cheng WYNTEK DIAGNOSTICS, INC. 6145 NANCY RIDGE DR. SUITE 101 San Diego, CA 92121 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-30 |
| Decision Date | 1997-02-04 |
| Summary: | summary |