AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK— 510(k) K132082
Substantially EquivalentAesku Diagnostics
FDA 510(k) clearance K132082 for AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK, Substantially Equivalent on 2013-12-05. Applicant: Aesku Diagnostics. Device class: 2.
Clearance details
- Applicant
- Aesku Diagnostics
- Product code
- Code MST
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- 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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