The following data is part of a premarket notification filed by Wyntek Diagnostics, Inc. with the FDA for Osom Hcg Combo Test.
| Device ID | K955141 |
| 510k Number | K955141 |
| Device Name: | OSOM HCG COMBO TEST |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-13 |
| Decision Date | 1995-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00742860100093 | K955141 | 000 |