FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOSIL D-DIMER
K Number: K073042
·
Decision Jul 31, 2008
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
56
Applicant Total
3
Review Days
276
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HEMOSIL D-DIMER
- K Number
- K073042
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentation Laboratory
- Date Received
- October 29, 2007
- Decision Date
- July 31, 2008
- Product Code
- DAP
- 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 |
|---|---|---|---|
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DAP), ordered by most recent decision date.
HemosIL D-Dimer HS 500
FDA 510(k)
FDA Class 2
·Hematology
STA® - Liatest® D-Di
FDA 510(k)
FDA Class 2
·Hematology
HemosIL D-Dimer HS
FDA 510(k)
FDA Class 2
·Hematology
HemosIL D-Dimer HS
FDA 510(k)
FDA Class 2
·Hematology
STA LIATEST D-DI
FDA 510(k)
FDA Class 2
·Hematology
VIDAS D-DIMER EXCLUSION II (DEX2)
FDA 510(k)
FDA Class 2
·Hematology