The following data is part of a premarket notification filed by Phadia Ab with the FDA for Immunocap Tryptase, Immunocap Tryptase Calibrators, Immunocap Tryptase Curve Control, Immunocap Tryptase Conjugate 50, Immunocap Tryptase Calibrator Strip, Immunocap Tryptase Curve Control Strip.
| Device ID | K173704 |
| 510k Number | K173704 |
| Device Name: | ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip |
| Classification | Tryptase Assay System |
| Applicant | Phadia AB Rapsgatan 7P Uppsala, SE 75137 |
| Contact | Carina Magnusson |
| Correspondent | Martin Mann Phadia US Inc 4169 Commercial Ave Portage, MI 49002 |
| Product Code | OYL |
| CFR Regulation Number | 866.5760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-04 |
| Decision Date | 2018-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066000916 | K173704 | 000 |
| 07333066000879 | K173704 | 000 |
| 07333066000862 | K173704 | 000 |
| 07333066000855 | K173704 | 000 |
| 07333066000909 | K173704 | 000 |
| 07333066000893 | K173704 | 000 |