AESKULISA ANA HEP-2, REF 30-7115US
FDA 510(k) clearance K081104 · decided 2008-05-02
Clearance details
- K-number
- K081104
- Device name
- AESKULISA ANA HEP-2, REF 30-7115US
- Applicant
- Aesku Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2008-04-18
- Decision date
- 2008-05-02
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- LKJ
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Wendelsheim, Rheinland, DE
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.