FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT
K Number: K130500
·
Decision Jul 26, 2013
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
28
Applicant Total
32
Review Days
150
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Basic Information
- Device Name
- CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT
- K Number
- K130500
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1630
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sebia
- Date Received
- February 26, 2013
- Decision Date
- July 26, 2013
- Product Code
- CEF
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| CEF | Electrophoretic, Protein Fractionation | FDA class 1 | Clinical Chemistry |
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