510(k) DEN120001
- Device
- IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE
- Applicant
- Phadia US, Inc.
- 510(k) number
- DEN120001
- Product code
- OYL
- Decision
- Unknown (DENG)
- Decision date
- 2012-02-15
- Date received
- 2012-01-12
- Regulation
- 866.5760
- Classification name
- Tryptase Assay System
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- MARTIN MANN
- Address
- 4169 Commercial Ave. Portage MI US 49002 49002
FDA Registration Numbers#
- 9610566
- 3004973408
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OYL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K173704 | ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip | Phadia AB | 2018-03-02 |