FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
K Number: K022053
·
Decision Jul 12, 2002
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
25
Applicant Total
32
Review Days
18
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Basic Information
- Device Name
- HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
- K Number
- K022053
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sebia
- Date Received
- June 24, 2002
- Decision Date
- July 12, 2002
- Product Code
- JHO
- 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 |
|---|---|---|---|
| JHO | Electrophoretic Separation, Lipoproteins | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JHO), ordered by most recent decision date.
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SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343
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LIPOPRINT SYSTEM, LDL SUBFRACTIONS
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