510(k) K173704
- Device
- ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip
- Applicant
- Phadia AB
- 510(k) number
- K173704
- Product code
- OYL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-03-02
- Date received
- 2017-12-04
- Regulation
- 866.5760
- Classification name
- Tryptase Assay System
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Carina Magnusson
- Address
- Rapsgatan 7p Uppsala SE 751 37 751 37
FDA Registration Numbers#
- 9610566
- 3004973408
Source Documents#
Other 510(k) Records For Product Code OYL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN120001 | IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE | Phadia US, Inc. | 2012-02-15 |
Legacy Summary#
summary
FDA Review#
Decision Summary