The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Pharmacia Cap System Phadiatop Feia.
| Device ID | K941993 |
| 510k Number | K941993 |
| Device Name: | PHARMACIA CAP SYSTEM PHADIATOP FEIA |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | PHARMACIA, INC. P.O. BOX 16529 Columbus, OH 43216 -6529 |
| Contact | Jean Frydman |
| Correspondent | Jean Frydman PHARMACIA, INC. P.O. BOX 16529 Columbus, OH 43216 -6529 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-25 |
| Decision Date | 1996-01-30 |