The following data is part of a premarket notification filed by Phadia Ab with the FDA for Immunocap Allergen F338, Scallop With Model(s): 14-4895-01.
| Device ID | K071913 |
| 510k Number | K071913 |
| Device Name: | IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01 |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | PHADIA AB BOX 6460 Uppsala, SE Se-751 37 |
| Contact | Karl-erik Backlund |
| Correspondent | Karl-erik Backlund PHADIA AB BOX 6460 Uppsala, SE Se-751 37 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-11 |
| Decision Date | 2007-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066004754 | K071913 | 000 |