FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS
K Number: K874607
·
Decision Jan 27, 1988
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
26
Applicant Total
130
Review Days
79
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Basic Information
- Device Name
- FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS
- K Number
- K874607
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Organon Teknika Corp.
- Date Received
- November 9, 1987
- Decision Date
- January 27, 1988
- Product Code
- LKN
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKN), ordered by most recent decision date.
AMICUS Separator System
FDA 510(k)
FDA Unclassified
·Unknown
Spectra Optia Apheresis System
FDA 510(k)
FDA Unclassified
·Unknown
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
FDA 510(k)
FDA Unclassified
·Unknown
Spectra Optia Apheresis System
FDA 510(k)
FDA Unclassified
·Unknown
Spectra Optia Apheresis System
FDA 510(k)
FDA Unclassified
·Unknown
Spectra Optia Apheresis System
FDA 510(k)
FDA Unclassified
·Unknown
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 |