FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CENTRICON -50 CONCENTRATOR
K Number: K930168
·
Decision Aug 5, 1993
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
14
Applicant Total
20
Review Days
204
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Basic Information
- Device Name
- CENTRICON -50 CONCENTRATOR
- K Number
- K930168
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2310
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Amicon, Inc.
- Date Received
- January 13, 1993
- Decision Date
- August 5, 1993
- Product Code
- JJH
- 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 |
|---|---|---|---|
| JJH | Clinical Sample Concentrator | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJH), ordered by most recent decision date.
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Other Clearances by Amicon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K853510 | MINIFILTER HEMOFILTER | Sep 12, 1985 | Substantially Equivalent |