FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set
K Number: K143470
·
Decision Jan 31, 2016
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
12
Applicant Total
41
Review Days
422
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Basic Information
- Device Name
- Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set
- K Number
- K143470
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7340
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diazyme Laboratories
- Date Received
- December 5, 2014
- Decision Date
- January 31, 2016
- Product Code
- GIS
- 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 |
|---|---|---|---|
| GIS | Test, Fibrinogen | FDA class 2 | Hematology |
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