The following data is part of a premarket notification filed by Phadia Ab with the FDA for Immunocap Rapid Inhalant Profile , Immunocap Rapid Reader, Immunocap Rapid Reader Check Device, And Immunocap Rapid Qc1.
| Device ID | K081830 |
| 510k Number | K081830 |
| Device Name: | IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | PHADIA AB 4169 COMMERCIAL AVENUE Portage, MI 49002 |
| Contact | Martin Mann |
| Correspondent | Martin Mann PHADIA AB 4169 COMMERCIAL AVENUE 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 | 2008-06-30 |
| Decision Date | 2009-03-16 |
| Summary: | summary |