The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Detect Group A Strep Test.
| Device ID | K834582 |
| 510k Number | K834582 |
| Device Name: | DETECT GROUP A STREP TEST |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | DIFCO LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-29 |
| Decision Date | 1984-04-04 |