AESKULISA ANA HEP-2, REF 30-7115US— 510(k) K081104
Substantially EquivalentAesku Diagnostics
FDA 510(k) clearance K081104 for AESKULISA ANA HEP-2, REF 30-7115US, Substantially Equivalent on 2008-05-02. Applicant: Aesku Diagnostics. Device class: 2.
Clearance details
- Applicant
- Aesku Diagnostics
- Product code
- Code LKJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wendelsheim, Rheinland, DE
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More clearances from Aesku Diagnostics
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