FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
K Number: K153117
·
Decision Jul 28, 2016
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
109
Applicant Total
1
Review Days
274
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Basic Information
- Device Name
- AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
- K Number
- K153117
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Aesku Systems GmbH&Co.Kg
- Date Received
- October 28, 2015
- Decision Date
- July 28, 2016
- Product Code
- DHN
- 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 |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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