The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Phadebas Rast(r)/phadezym(r) Rast Allergen Disc.
| Device ID | K893132 |
| 510k Number | K893132 |
| Device Name: | PHADEBAS RAST(R)/PHADEZYM(R) RAST ALLERGEN DISC |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| 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 | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-25 |
| Decision Date | 1989-06-02 |