The following data is part of a premarket notification filed by Wyntek Diagnostics, Inc. with the FDA for Osom Ultra Strep A Test, Model 147.
| Device ID | K992658 |
| 510k Number | K992658 |
| Device Name: | OSOM ULTRA STREP A TEST, MODEL 147 |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| 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 | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-09 |
| Decision Date | 2000-01-18 |