FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
AUTOMATED 8400 BLOOD CELL SEPARATOR
K Number: K831004
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
26
Applicant Total
8
Review Days
167
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Basic Information
- Device Name
- AUTOMATED 8400 BLOOD CELL SEPARATOR
- K Number
- K831004
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Intl. Business Machines
- Date Received
- March 29, 1983
- Decision Date
- September 12, 1983
- 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.
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AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
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FDA 510(k)
FDA Unclassified
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Spectra Optia Apheresis System
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Intl. Business Machines
| K Number | Device Name | ||
|---|---|---|---|
| K830163 | IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS | Feb 18, 1983 | Substantially Equivalent |
| K812355 | IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2 | Sep 9, 1981 | Substantially Equivalent |
| K810988 | IBM 5885 DIGITAL ECG ACQUISITION CART | May 1, 1981 | Substantially Equivalent |
| K810989 | IBM 5880 ACQUISITION & ANALYSIS CART TEL | May 1, 1981 | Substantially Equivalent |
| K772353 | EKG ACQUISITION & ANALYSIS CART | Jan 6, 1978 | Substantially Equivalent |
| K771258 | BLOOD CELL SEPARATOR 2997 | Sep 6, 1977 | Substantially Equivalent |
| K760856 | BLOOD CELL PROCESSOR MODEL 2 IBM 2991 | Jan 10, 1977 | Substantially Equivalent |