The following data is part of a premarket notification filed by Scott Laboratories, Inc. with the FDA for Sero-stat Staphylococcus Test.
| Device ID | K811098 |
| 510k Number | K811098 |
| Device Name: | SERO-STAT STAPHYLOCOCCUS TEST |
| Classification | Kit, Screening, Staphylococcus Aureus |
| Applicant | SCOTT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JWX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-22 |
| Decision Date | 1981-05-05 |