FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AESKULISA ANA HEP-2
K Number: K040953
·
Decision Jun 23, 2004
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
111
Applicant Total
6
Review Days
72
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Basic Information
- Device Name
- AESKULISA ANA HEP-2
- K Number
- K040953
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Aesku, Inc.
- Date Received
- April 12, 2004
- Decision Date
- June 23, 2004
- Product Code
- LJM
- 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 |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | FDA class 2 | Immunology |
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Other Clearances by Aesku, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K062217 | AESKULSKA BETA2-GLYCO-A | Dec 13, 2006 | Substantially Equivalent |
| K051492 | AESKULISA ASCA A | Nov 14, 2005 | Substantially Equivalent |
| K042644 | AESKULISA TTG A AND AESKULISA TTG G | Jun 1, 2005 | Substantially Equivalent |
| K040463 | AESKULISA CARDIOLIPIN AGM | May 12, 2004 | Substantially Equivalent |
| K032469 | AESKULISA ANA 8PRO | Dec 16, 2003 | Substantially Equivalent |