FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMICON ULTRAFILTRATION MEMBRANES CMII
K Number: K810810
·
Decision Apr 17, 1981
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
27
Applicant Total
20
Review Days
24
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Basic Information
- Device Name
- AMICON ULTRAFILTRATION MEMBRANES CMII
- K Number
- K810810
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Amicon, Inc.
- Date Received
- March 24, 1981
- Decision Date
- April 17, 1981
- Product Code
- DHX
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| DHX | System, Test, Carcinoembryonic Antigen | FDA class 2 | Immunology |
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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 |