MODIFICATION TO AESKULISA DS DNA G— 510(k) K081251
Substantially EquivalentAesku Diagnostics
FDA 510(k) clearance K081251 for MODIFICATION TO AESKULISA DS DNA G, Substantially Equivalent on 2008-05-13. Applicant: Aesku Diagnostics. Device class: 2.
Clearance details
- Applicant
- Aesku Diagnostics
- Product code
- Code LSW
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Wendelsheim, Rheinland, DE
Recent devices under product code LSW
view all- K172348 — AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10
- K152013 — QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
- K072393 — ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
- K060380 — FIDIS DSDNA
- K041628 — AESKULISA DS DNA G
More clearances from Aesku Diagnostics
view allData sourced from openFDA. This site is unofficial and independent of the FDA.