The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Delfia (tm) Hige Kit.
| Device ID | K884545 |
| 510k Number | K884545 |
| Device Name: | DELFIA (TM) HIGE KIT |
| Classification | Ige, Antigen, Antiserum, Control |
| 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 | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-31 |
| Decision Date | 1988-11-10 |