The following data is part of a premarket notification filed by Scott Laboratories, Inc. with the FDA for Sero-stat Streptococcus Test.
| Device ID | K790492 |
| 510k Number | K790492 |
| Device Name: | SERO-STAT STREPTOCOCCUS TEST |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | SCOTT 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 | 1979-03-13 |
| Decision Date | 1979-05-01 |