Medical Device Manufacturer · US , Indianapolis , IN

Seradyn, Inc.

28 submissions · 28 cleared · Since 1988
28
Total
28
Cleared
0
Denied

Seradyn, Inc. — FDA 510(k) Submissions

Seradyn, Inc. has submitted 28 FDA 510(k) premarket notifications since 1988, of which 28 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Calibrator, Secondary, Immunoassay, Anti-seizure Drug, Enzyme Immunoassay, Gentamicin, Fluorometric, Cortisol, Nephelometric Inhibition Immunoassay, Phenobarbital . Use the specialty filter in the sidebar to narrow results.

28 devices
1–25 of 28
SERADYN QMS TOPIRAMATE
K070645 · NWM Immunoassay, Anti-seizure... · Toxicology
May 2007 70d
QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS
K062966 · ORH Lamotrigine Assay · Chemistry
Jan 2007 105d
ARCHITECT CORTISOL ASSAY
K062204 · JFT Fluorometric, Cortisol · Chemistry
Sep 2006 52d
QMS TOBRAMYCIN
K060998 · LCR Fluorescent Immunoassay,... · Chemistry
Jul 2006 101d
MULTIGENT GENTAMICIN
K060709 · LCD Enzyme Immunoassay,... · Toxicology
Jun 2006 91d
QMS QUINIDINE. QMS QUINIDINE CALIBRATORS
K052826 · LBZ Enzyme Immunoassay,... · Toxicology
Dec 2005 79d
QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS
K051211 · NWM Immunoassay, Anti-seizure... · Chemistry
Nov 2005 191d
QMS AMIKACIN REAGENTS
K052815 · KLQ Radioimmunoassay, Amikacin · Toxicology
Nov 2005 28d
QMS VANCOMYCIN
K050419 · LEH Radioimmunoassay, Vancomycin · Toxicology
Apr 2005 42d
ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)
K042307 · JIT Calibrator, Secondary · Chemistry
Nov 2004 70d
MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
K033674 · LCP Assay, Glycosylated... · Chemistry
Feb 2004 77d
COLOR-SLIDE RF
K981496 · DHR System, Test, Rheumatoid... · Immunology
Jun 1998 49d
COLORSLIDER RUBELLA
K952544 · LQN Latex Agglutination... · Microbiology
Jan 1996 229d
QMS THEOPHYLLINE CS
K942991 · LGS Fluorescence Polarization... · Toxicology
Sep 1994 81d
QMS CARBAMAZEPINE ASSAY
K940374 · KLT Enzyme Immunoassay,... · Toxicology
Jun 1994 127d
QMS GENTAMICIN ASSAY
K940376 · LCD Enzyme Immunoassay,... · Toxicology
Jun 1994 127d
VALPROIC ACID
K936208 · LEG Enzyme Immunoassay,... · Chemistry
Mar 1994 72d
QMS PHENOBARBITAL
K934388 · LFN Nephelometric Inhibition... · Toxicology
Feb 1994 169d
ELECTROPHORESIS CONTROL LEVEL 1
K925326 · JJY Multi-analyte Controls,... · Chemistry
Mar 1993 156d
LPIA-FERRITIN ASSAY
K924186 · DEF Alpha-2-hs-glycoprotein,... · Immunology
Dec 1992 125d
QMS - DIGOXIN
K913562 · LCS Radioimmunoassay, Digoxin... · Chemistry
Aug 1991 21d
COLOR VUE TM- MYCOPLASMA PNEUMONIAE
K910833 · GSA Antisera, All Mycoplasma... · Microbiology
Jun 1991 117d
ELECTROPHORESIS CONTROL
K910160 · JIT Calibrator, Secondary · Chemistry
Feb 1991 43d
CK-MB IMMUNOASSAY CONTROL
K905623 · JJT Enzyme Controls (assayed... · Chemistry
Feb 1991 70d
QMS TM- PHENYTOIN
K904815 · DIP Enzyme Immunoassay,... · Chemistry
Nov 1990 13d
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