FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)
K Number: K011113
·
Decision Jun 13, 2001
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
25
Applicant Total
32
Review Days
63
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Basic Information
- Device Name
- HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)
- K Number
- K011113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sebia
- Date Received
- April 11, 2001
- Decision Date
- June 13, 2001
- Product Code
- CIN
- 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 |
|---|---|---|---|
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | FDA class 2 | Clinical Chemistry |
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