The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Immunocap Allergen K82.
| Device ID | K121463 |
| 510k Number | K121463 |
| Device Name: | IMMUNOCAP ALLERGEN K82 |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | Thermo Fisher Scientific 4169 COMMERCIAL AVENUE Portage, MI 49002 |
| Contact | Martin Mann |
| Correspondent | Martin Mann Thermo Fisher Scientific 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 | 2012-05-17 |
| Decision Date | 2013-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066004051 | K121463 | 000 |