The following data is part of a premarket notification filed by Pharmacia & Upjohn Co. with the FDA for Allergen Immundocap Modelc5, C6, C73, E201, E213, F50, F51,f54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F.
| Device ID | K993388 |
| 510k Number | K993388 |
| Device Name: | ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F |
| 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 | 1999-10-08 |
| Decision Date | 1999-12-01 |
| Summary: | summary |