The following data is part of a premarket notification filed by Pharmacia & Upjohn Co. with the FDA for Allergen Immunocap, Models E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2.
Device ID | K991048 |
510k Number | K991048 |
Device Name: | ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2 |
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 | 1999-03-30 |
Decision Date | 1999-05-14 |
Summary: | summary |