The following data is part of a premarket notification filed by Scott Laboratories, Inc. with the FDA for Sero-stat R Ii Staphylococcus Test.
| Device ID | K863025 |
| 510k Number | K863025 |
| Device Name: | SERO-STAT R II STAPHYLOCOCCUS TEST |
| Classification | Staphylococcus Aureus Somatic Antigens |
| Applicant | SCOTT LABORATORIES, INC. Fiskeville, RI 02823 |
| Contact | Paul Campognone |
| Correspondent | Paul Campognone SCOTT LABORATORIES, INC. Fiskeville, RI 02823 |
| Product Code | LHT |
| CFR Regulation Number | 866.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-11 |
| Decision Date | 1986-09-15 |