The following data is part of a premarket notification filed by Excel Scientific, Inc. with the FDA for Excel Onestep Group A Strep Antigen Module Test Kit.
| Device ID | K962146 |
| 510k Number | K962146 |
| Device Name: | EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | EXCEL SCIENTIFIC, INC. 23071 LA PALMA AVE. Yorba Linda, CA 92887 |
| Contact | Min-lee Cheng |
| Correspondent | Min-lee Cheng EXCEL SCIENTIFIC, INC. 23071 LA PALMA AVE. Yorba Linda, CA 92887 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-03 |
| Decision Date | 1996-10-07 |
| Summary: | summary |