FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
K Number: K112120
·
Decision Jan 24, 2013
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
27
Applicant Total
41
Review Days
549
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Basic Information
- Device Name
- DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
- K Number
- K112120
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diazyme Laboratories
- Date Received
- July 25, 2011
- Decision Date
- January 24, 2013
- Product Code
- GHH
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GHH | Fibrin Split Products | FDA class 2 | Hematology |
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