FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MDA D-DIMER
K Number: K000492
·
Decision Jun 7, 2000
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
56
Applicant Total
130
Review Days
113
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Basic Information
- Device Name
- MDA D-DIMER
- K Number
- K000492
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Organon Teknika Corp.
- Date Received
- February 15, 2000
- Decision Date
- June 7, 2000
- 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 |
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|---|---|---|---|
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| K994343 | BACT/ALERT SV | Feb 10, 2000 | Substantially Equivalent |
| K993423 | BACT/ALERT SA | Dec 15, 1999 | Substantially Equivalent |
| K993421 | BACT/ALERT SN | Dec 14, 1999 | Substantially Equivalent |
| K993576 | BACT/ALERT MP PROCESS BOTTLE | Dec 14, 1999 | Substantially Equivalent |
| K992432 | BACT/ALERT FN | Sep 24, 1999 | Substantially Equivalent |
| K983762 | NUCLISENS CMV PP67 | Sep 15, 1999 | Substantially Equivalent |
| K992401 | BACT/ALERT PF | Sep 3, 1999 | Substantially Equivalent |
| K992400 | BACTALERT FA | Sep 3, 1999 | Substantially Equivalent |