The following data is part of a premarket notification filed by Phadia Ab with the FDA for Immunocap Allergen E229, Allergen Component Rcan F 4 Dog, Immunocap Allergen E230, Allergen Component Rcan F 6 Dog, Immunocap Allergen E231, Allergen Component Rfel D 7 Cat.
| Device ID | K190315 |
| 510k Number | K190315 |
| Device Name: | ImmunoCAP Allergen E229, Allergen Component RCan F 4 Dog, ImmunoCAP Allergen E230, Allergen Component RCan F 6 Dog, ImmunoCAP Allergen E231, Allergen Component RFel D 7 Cat |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | Phadia AB Rapsgatan 7P Uppsala, SE 75137 |
| Contact | Ulf Karlberg |
| Correspondent | Sheryl Skinner Phadia US Inc 4169 Commercial Ave Portage, MI 49002 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-13 |
| Decision Date | 2019-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066016924 | K190315 | 000 |
| 07333066016917 | K190315 | 000 |
| 07333066011011 | K190315 | 000 |