The following data is part of a premarket notification filed by Pharmacia & Upjohn Co. with the FDA for Pharmacia Cap System Rast Feia.
| Device ID | K962976 |
| 510k Number | K962976 |
| Device Name: | PHARMACIA CAP SYSTEM RAST FEIA |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | PHARMACIA & UPJOHN CO. 3 BETHESDA METRO CENTER SUITE 750 Bethesda, MD 20814 |
| Contact | Joyce Davis |
| Correspondent | Joyce Davis PHARMACIA & UPJOHN CO. 3 BETHESDA METRO CENTER SUITE 750 Bethesda, MD 20814 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-31 |
| Decision Date | 1996-12-23 |
| Summary: | summary |