The following data is part of a premarket notification filed by Pharmacia & Upjohn Co. with the FDA for Allergen Immunocap Models D73, D74, E71, E72, E73, E74 E75, E76,e82,e88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3.
| Device ID | K982343 |
| 510k Number | K982343 |
| Device Name: | ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3 |
| 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 | 1998-07-06 |
| Decision Date | 1998-09-15 |
| Summary: | summary |