Medical Device Manufacturer · US , Arlington , MA

Reference Diagnostics, Inc. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 1990

17

Total

17

Cleared

0

Denied

FDA 510(k) Regulatory Record - Reference Diagnostics, Inc. Chemistry ✕

14 devices

1-14 of 14

Cleared Mar 13, 2006

FERRITIN CALIBRATOR SET, CATALOG NO. 8203

Chemistry · 108d

Cleared Nov 09, 2005

TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET

Chemistry · 93d

Cleared Sep 30, 2003

EXTENDED RANGE HS CRP KIT, CAT NO:9200

Chemistry · 267d

Cleared Jun 27, 2002

Chemistry · 42d

Cleared May 04, 2000

DIRECT TIBC CALIBRATOR

Chemistry · 55d

Cleared May 02, 2000

DIRECT TIBC KIT

Chemistry · 53d

Cleared Feb 16, 1999

MAGNETIC TIBC KIT

Chemistry · 25d

Cleared Jan 28, 1999

RDI DIRECT LDL CHOLESTEROL TEST

Chemistry · 72d

Cleared Dec 22, 1997

RDI HOMOGENEOUS HDL CHOLESTEROL TEST

Chemistry · 62d

Cleared Nov 20, 1996

RDI LDL PRECIPITATION REAGENT

Chemistry · 41d

Cleared Nov 20, 1996

RDI LIPIDIRECT MAGNETIC LDL REAGENT

Chemistry · 41d

Cleared Aug 02, 1995

MAGNETIC HDL CHOLESTEROL TEST

Chemistry · 295d

Cleared Jul 18, 1991

MAGNETIC HDL CHOLESTEROL TEST

Chemistry · 79d

Cleared Mar 19, 1990

LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES

Chemistry · 306d