FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE
K Number: DEN120001
·
Decision Feb 15, 2012
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
1
Applicant Total
22
Review Days
34
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Basic Information
- Device Name
- IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE
- K Number
- DEN120001
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 866.5760
- Medical Specialty
- Immunology
- Decision
- Unknown
- Applicant
- Phadia US, Inc.
- Date Received
- January 12, 2012
- Decision Date
- February 15, 2012
- Product Code
- OYL
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OYL | Tryptase Assay System | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OYL), ordered by most recent decision date.
View allOther Clearances by Phadia US, Inc.
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