The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Phadebact Monoclonal Gc Test.
| Device ID | K850351 |
| 510k Number | K850351 |
| Device Name: | PHADEBACT MONOCLONAL GC TEST |
| Classification | Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae |
| 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 | LIC |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-28 |
| Decision Date | 1985-03-13 |