The following data is part of a premarket notification filed by Kabi Pharmacia, Inc. with the FDA for Pharmacia Cap System Ige Feia -- Modification.
| Device ID | K923832 |
| 510k Number | K923832 |
| Device Name: | PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | KABI PHARMACIA, INC. P.O. BOX 10087 New Brunswick, NJ 08906 |
| Contact | Mayo |
| Correspondent | Mayo KABI PHARMACIA, INC. P.O. BOX 10087 New Brunswick, NJ 08906 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-28 |
| Decision Date | 1992-11-25 |