FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
AESKULISA ANA HEP-2, REF 30-7115US
K Number: K081104
·
Decision May 2, 2008
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
49
Applicant Total
9
Review Days
14
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Basic Information
- Device Name
- AESKULISA ANA HEP-2, REF 30-7115US
- K Number
- K081104
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Aesku Diagnostics
- Date Received
- April 18, 2008
- Decision Date
- May 2, 2008
- Product Code
- LKJ
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LKJ | Antinuclear Antibody, Antigen, Control | FDA class 2 | Immunology |
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Other Clearances by Aesku Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K132082 | AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK | Dec 5, 2013 | Substantially Equivalent |
| K120889 | AESKUSLIDES ANA HEP-2 | Oct 15, 2012 | Substantially Equivalent |
| K091859 | AESKU PR3 | Jun 3, 2010 | Substantially Equivalent |
| K091860 | AESKULISA MPO, MODEL 30-7303US | Feb 23, 2010 | Substantially Equivalent |
| K081251 | MODIFICATION TO AESKULISA DS DNA G | May 13, 2008 | Substantially Equivalent |
| K052439 | AESKULISA GLIA A AND AESKULISA GLIA G | Feb 7, 2006 | Substantially Equivalent |
| K041628 | AESKULISA DS DNA G | Oct 14, 2004 | Substantially Equivalent |
| K041753 | AESKULISA ENA 6 S | Jul 14, 2004 | Substantially Equivalent |