The following data is part of a premarket notification filed by Wyntek Diagnostics, Inc. with the FDA for Osom Card Ii Hcg-urine Test, Model 102.
| Device ID | K990578 |
| 510k Number | K990578 |
| Device Name: | OSOM CARD II HCG-URINE TEST, MODEL 102 |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| 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 | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-23 |
| Decision Date | 1999-03-09 |
| Summary: | summary |