The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Immunocap Rapid Reader, Model 12-3600-10.
| Device ID | K092978 |
| 510k Number | K092978 |
| Device Name: | IMMUNOCAP RAPID READER, MODEL 12-3600-10 |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Contact | Martin Mann |
| Correspondent | Martin Mann 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 | 2009-09-28 |
| Decision Date | 2010-01-19 |
| Summary: | summary |