The following data is part of a premarket notification filed by Pharmacia & Upjohn Co. with the FDA for Pharmacia Cap System Ige Feia, Model 10-9395-01.
| Device ID | K991945 |
| 510k Number | K991945 |
| Device Name: | PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | PHARMACIA & UPJOHN CO. 5094 ST. ANDREWS DR. Westervillle, OH 43082 |
| Contact | Karen E Matis |
| Correspondent | Karen E Matis PHARMACIA & UPJOHN CO. 5094 ST. ANDREWS DR. Westervillle, OH 43082 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-09 |
| Decision Date | 1999-07-28 |
| Summary: | summary |