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 ↓

Total

Cleared

Denied

Aesku Diagnostics has 9 FDA 510(k) cleared medical devices. Based in Miami, US.

Historical record: 9 cleared submissions from 2004 to 2013. Primary specialty: Immunology.

Browse the FDA 510(k) cleared devices submitted by Aesku Diagnostics Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Intertek Testing Services as regulatory consultant.

Aesku Diagnostics is one of 18943 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Aesku Diagnostics

9 devices

1-9 of 9

Cleared Dec 05, 2013

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

K132082 · MST

Immunology · 153d

Cleared Oct 15, 2012

AESKUSLIDES ANA HEP-2

AESKULISA MPO, MODEL 30-7303US

K091860 · MOB

Immunology · 249d

Cleared May 13, 2008

MODIFICATION TO AESKULISA DS DNA G

K081251 · LSW

Immunology · 11d

Cleared May 02, 2008

AESKULISA ANA HEP-2, REF 30-7115US

K081104 · LKJ

Immunology · 14d

Cleared Feb 07, 2006

AESKULISA GLIA A AND AESKULISA GLIA G

Aesku Diagnostics - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Aesku Diagnostics

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