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 |