The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Shigella I.d..
| Device ID | K821337 |
| 510k Number | K821337 |
| Device Name: | SHIGELLA I.D. |
| Classification | Antisera, All Types, Shigella Spp. |
| Applicant | ANALYTICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GNB |
| CFR Regulation Number | 866.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-05 |
| Decision Date | 1982-05-28 |