The following data is part of a premarket notification filed by Wyntek Diagnostics, Inc. with the FDA for Osom Strep A Test.
| Device ID | K961423 |
| 510k Number | K961423 |
| Device Name: | OSOM STREP A TEST |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| 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 | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-12 |
| Decision Date | 1996-10-11 |
| Summary: | summary |