FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CENTRIFREE MICROPARTITION SYSTEM
K Number: K820455
·
Decision Mar 15, 1982
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
8
Applicant Total
20
Review Days
24
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Basic Information
- Device Name
- CENTRIFREE MICROPARTITION SYSTEM
- K Number
- K820455
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Amicon, Inc.
- Date Received
- February 19, 1982
- Decision Date
- March 15, 1982
- Product Code
- JRL
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JRL | Unit, Filter, Membrane | FDA class 1 | Clinical Chemistry |
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Other Clearances by Amicon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K930168 | CENTRICON -50 CONCENTRATOR | Aug 5, 1993 | Substantially Equivalent |
| K902837 | AMICON DIAFILTER 30 HEMOCONCENTRATOR | Nov 1, 1990 | Substantially Equivalent |
| K901286 | AMICON HEMOCONCENTRATOR SET | May 18, 1990 | Substantially Equivalent |
| K900280 | CENTRIPREP 100 | Feb 16, 1990 | Substantially Equivalent |
| K895405 | AMICON MINIFILTER PLUS HEMOFILTER | Jan 11, 1990 | Substantially Equivalent |
| K893733 | CENTRICON CONCENTRATOR | Jul 20, 1989 | Substantially Equivalent |
| K892645 | AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY | Jun 13, 1989 | Substantially Equivalent |
| K875121 | AMICON EQUALINE FLUID BALANCE SYSTEM | Feb 19, 1988 | Substantially Equivalent |
| K870690 | CENTRIPREP CONCENTRATOR | Mar 19, 1987 | Substantially Equivalent |
| K863823 | AMICON DIAFILTER HEMOFILTER | Nov 6, 1986 | Substantially Equivalent |