Medical Device Manufacturer · US , Miami , FL

Aesku Diagnostics - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2004

Recent clearances: AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK, AESKUSLIDES ANA HEP-2, AESKU PR3

View 9 510(k) Devices ↓

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Aesku Diagnostics Immunology ✕

9 devices

1-9 of 9

Cleared Dec 05, 2013

AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK

Immunology · 153d

Cleared Oct 15, 2012

AESKUSLIDES ANA HEP-2

Immunology · 206d

Cleared Jun 03, 2010

Immunology · 349d

Cleared Feb 23, 2010

AESKULISA MPO, MODEL 30-7303US

Immunology · 249d

Cleared May 13, 2008

MODIFICATION TO AESKULISA DS DNA G

Immunology · 11d

Cleared May 02, 2008

AESKULISA ANA HEP-2, REF 30-7115US

Immunology · 14d

Cleared Feb 07, 2006

AESKULISA GLIA A AND AESKULISA GLIA G

Immunology · 154d

Cleared Oct 14, 2004

AESKULISA DS DNA G

Immunology · 120d

Cleared Jul 14, 2004

AESKULISA ENA 6 S

Immunology · 15d