FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT
K Number: K951966
·
Decision Jun 1, 1995
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
10
Applicant Total
40
Review Days
35
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Basic Information
- Device Name
- HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT
- K Number
- K951966
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5060
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kent Laboratories, Inc.
- Date Received
- April 27, 1995
- Decision Date
- June 1, 1995
- Product Code
- JZJ
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JZJ | Prealbumin, Antigen, Antiserum, Control | FDA class 1 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JZJ), ordered by most recent decision date.
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FDA 510(k)
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Other Clearances by Kent Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951967 | HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT | May 30, 1995 | Substantially Equivalent |
| K951968 | HUMAN C1Q RADIAL IMMUNODIFFUSION KIT | May 30, 1995 | Substantially Equivalent |
| K950102 | HUMAN C-5 RADIAL IMMUNODIFFUSION KIT | Apr 10, 1995 | Substantially Equivalent |
| K850683 | 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 | Nov 27, 1985 | Substantially Equivalent |
| K850682 | 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL | Nov 25, 1985 | Substantially Equivalent |
| K850691 | ANTISERUM TO HUMAN APOLIPOPROTEIN A-I | Nov 1, 1985 | Substantially Equivalent |
| K850690 | ANTISERUM TO HUMAN APOLIPOPROTEIN B | Nov 1, 1985 | Substantially Equivalent |
| K850686 | ANTISERUM TO HUMAN PREALBUMIN | Nov 1, 1985 | Substantially Equivalent |
| K831961 | IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN | Aug 11, 1983 | Substantially Equivalent |
| K831958 | RADIAL IMMUNO-TEST FOR HUMAN C-REACTI | Jul 19, 1983 | Substantially Equivalent |