The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Phadebact Shigella Test.
| Device ID | K880752 |
| 510k Number | K880752 |
| Device Name: | PHADEBACT SHIGELLA TEST |
| Classification | Antisera, All Types, Shigella Spp. |
| Applicant | PHARMACIA, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08854 -3911 |
| Contact | Albert P Mayo |
| Correspondent | Albert P Mayo PHARMACIA, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08854 -3911 |
| Product Code | GNB |
| CFR Regulation Number | 866.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-24 |
| Decision Date | 1989-02-17 |