Seradyn, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Seradyn, Inc. - FDA 510(k) Cleared Devices
28
Total
28
Cleared
0
Denied
Seradyn, Inc. has 28 FDA 510(k) cleared medical devices. Based in Indianapolis, US.
Historical record: 28 cleared submissions from 1988 to 2007. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Seradyn, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Seradyn, Inc.
28 devices
Cleared
May 17, 2007
SERADYN QMS TOPIRAMATE
Toxicology
70d
Cleared
Jan 12, 2007
QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS
Chemistry
105d
Cleared
Sep 22, 2006
ARCHITECT CORTISOL ASSAY
Chemistry
52d
Cleared
Jul 21, 2006
QMS TOBRAMYCIN
Chemistry
101d
Cleared
Jun 15, 2006
MULTIGENT GENTAMICIN
Toxicology
91d
Cleared
Dec 23, 2005
QMS QUINIDINE. QMS QUINIDINE CALIBRATORS
Toxicology
79d
Cleared
Nov 18, 2005
QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS
Chemistry
191d
Cleared
Nov 01, 2005
QMS AMIKACIN REAGENTS
Toxicology
28d
Cleared
Apr 01, 2005
QMS VANCOMYCIN
Toxicology
42d
Cleared
Nov 03, 2004
ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)
Chemistry
70d
Cleared
Feb 09, 2004
MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
Chemistry
77d
Cleared
Jun 15, 1998
COLOR-SLIDE RF
Immunology
49d