The following data is part of a premarket notification filed by Burroughs Wellcome Co. with the FDA for Strep-tex.
| Device ID | K781607 |
| 510k Number | K781607 |
| Device Name: | STREP-TEX |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | BURROUGHS WELLCOME CO. 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 | 1978-09-18 |
| Decision Date | 1978-10-17 |