The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Modified Delfia Estradiol Kit.
| Device ID | K902358 |
| 510k Number | K902358 |
| Device Name: | MODIFIED DELFIA ESTRADIOL KIT |
| Classification | Radioimmunoassay, Estradiol |
| 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 | CHP |
| CFR Regulation Number | 862.1260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-29 |
| Decision Date | 1990-06-18 |