The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Salmonella & Shigella Grouping Sera.
| Device ID | K820996 |
| 510k Number | K820996 |
| Device Name: | SALMONELLA & SHIGELLA GROUPING SERA |
| Classification | Antigens, All Groups, Salmonella Spp. |
| Applicant | FISHER SCIENTIFIC CO., LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GRL |
| CFR Regulation Number | 866.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-09 |
| Decision Date | 1982-05-03 |