FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
AUTOMATED BLOOD CELL SEPARATOR
K Number: K830831
·
Decision Jun 16, 1983
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
26
Applicant Total
6
Review Days
92
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Basic Information
- Device Name
- AUTOMATED BLOOD CELL SEPARATOR
- K Number
- K830831
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Cryosan, Inc.
- Date Received
- March 16, 1983
- Decision Date
- June 16, 1983
- Product Code
- LKN
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| 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
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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
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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 Cryosan, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K831953 | INFUSION PUMP | Jul 19, 1983 | Substantially Equivalent |
| K822521 | AUTOMATED BLOOD CELL SEPARATOR | Sep 30, 1982 | Substantially Equivalent |
| K813489 | ROCKING/CIRCULATING CYTO-THERM II 3570 | Mar 4, 1982 | Substantially Equivalent |
| K812309 | CRYOSAN NORMAL SALINE | Sep 16, 1981 | Substantially Equivalent |
| K812311 | CIRCULATING CYTO-THERMS | Sep 16, 1981 | Substantially Equivalent |