The following data is part of a premarket notification filed by Wyntek Diagnostics, Inc. with the FDA for Osom Hcg-urine Test Model 101.
| Device ID | K974159 |
| 510k Number | K974159 |
| Device Name: | OSOM HCG-URINE TEST MODEL 101 |
| 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 | 1997-10-14 |
| Decision Date | 1997-12-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00742860100154 | K974159 | 000 |
| 00742860100086 | K974159 | 000 |
| 00742860001017 | K974159 | 000 |