Medical Device Manufacturer · US , Boise , ID

Kronus Market Development Associates, Inc. - FDA 510(k) Cleared Devic...

11 submissions · 10 cleared · Since 2003

11

Total

10

Cleared

1

Denied

FDA 510(k) Regulatory Record - Kronus Market Development Associates, Inc. Immunology ✕

11 devices

1-11 of 11

Not Cleared Aug 20, 2014

ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT

DEN140001 · PHF

Immunology · 65d

Cleared Dec 20, 2012

STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT

Immunology · 258d

Cleared May 30, 2012

KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT

Immunology · 324d

Cleared Jun 17, 2008

KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT

Immunology · 112d

Cleared May 22, 2008

KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT

Immunology · 120d

Cleared Apr 10, 2008

KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT

Immunology · 112d

Cleared Nov 07, 2007

KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT

Immunology · 97d

Cleared Jul 13, 2007

KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT

Immunology · 175d

Cleared Nov 04, 2005

KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT

Immunology · 192d

Cleared Dec 17, 2004

KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT

Immunology · 120d

Cleared Sep 10, 2003

TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT

Immunology · 61d