The following data is part of a premarket notification filed by Pharmacia & Upjohn Co. with the FDA for Allergen Immunocap, Models C74, E89, Ex2, Ex70, Ex71, Ex73, Fx8, Fx9, Fx10, Fx16, Fx73, I72, I75, I76, K71, K73, K81, K8.
| Device ID | K000132 |
| 510k Number | K000132 |
| Device Name: | ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8 |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| 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 | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-18 |
| Decision Date | 2000-02-18 |