Medical Device Manufacturer · US , Indianapolis , IN

Seradyn, Inc. - FDA 510(k) Cleared Devices

28 submissions · 28 cleared · Since 1988

28

Total

28

Cleared

0

Denied

FDA 510(k) Regulatory Record - Seradyn, Inc. Toxicology ✕

9 devices

1-9 of 9

Cleared May 17, 2007

SERADYN QMS TOPIRAMATE

Toxicology · 70d

Cleared Jun 15, 2006

MULTIGENT GENTAMICIN

Toxicology · 91d

Cleared Dec 23, 2005

QMS QUINIDINE. QMS QUINIDINE CALIBRATORS

Toxicology · 79d

Cleared Nov 01, 2005

QMS AMIKACIN REAGENTS

Toxicology · 28d

Cleared Apr 01, 2005

Toxicology · 42d

Cleared Sep 09, 1994

QMS THEOPHYLLINE CS

Toxicology · 81d

Cleared Jun 02, 1994

QMS CARBAMAZEPINE ASSAY

Toxicology · 127d

Cleared Jun 02, 1994

QMS GENTAMICIN ASSAY

Toxicology · 127d

Cleared Feb 25, 1994

QMS PHENOBARBITAL

Toxicology · 169d