FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIBRINOSTICON
K Number: K880077
·
Decision Feb 9, 1988
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
27
Applicant Total
130
Review Days
29
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Basic Information
- Device Name
- FIBRINOSTICON
- K Number
- K880077
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Organon Teknika Corp.
- Date Received
- January 11, 1988
- Decision Date
- February 9, 1988
- 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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Other Clearances by Organon Teknika Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K003104 | BACT/ALERT CSR | Oct 20, 2000 | Substantially Equivalent |
| K000492 | MDA D-DIMER | Jun 7, 2000 | Substantially Equivalent |
| K000378 | BACT/ALERT MB CULTURE BOTTLE | Mar 2, 2000 | Substantially Equivalent |
| 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 |