Medical Device Manufacturer · US , Arlington , MA

Reference Diagnostics, Inc.

17 submissions · 17 cleared · Since 1990
17
Total
17
Cleared
0
Denied

Reference Diagnostics, Inc. — FDA 510(k) Submissions

Reference Diagnostics, Inc. has submitted 17 FDA 510(k) premarket notifications since 1990, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Calibrator, Secondary, System, Test, Low Density, Lipoprotein, Ferrozine (colorimetric) Iron Binding Capacity, C-reactive Protein, Antigen, Antiserum, And Control, Ldl & Vldl Precipitation, Hdl . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
RDI HSFERRITIN KIT
K053211 · DBF Ferritin, Antigen,... · Immunology
Mar 2006 117d
FERRITIN CALIBRATOR SET, CATALOG NO. 8203
K053291 · JIT Calibrator, Secondary · Chemistry
Mar 2006 108d
TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET
K052148 · JIT Calibrator, Secondary · Chemistry
Nov 2005 93d
EXTENDED RANGE HS CRP KIT, CAT NO:9200
K030044 · DCK C-reactive Protein,... · Chemistry
Sep 2003 267d
RDI EXTENDED RANGE CRP CALIBRATOR SET
K030772 · JIT Calibrator, Secondary · Immunology
Apr 2003 31d
RDI HS CRP CALIBRATOR SET
K021607 · JIT Calibrator, Secondary · Immunology
Jun 2002 42d
RDI HS CRP KIT
K021609 · DCK C-reactive Protein,... · Chemistry
Jun 2002 42d
DIRECT TIBC CALIBRATOR
K000783 · JIT Calibrator, Secondary · Chemistry
May 2000 55d
DIRECT TIBC KIT
K000781 · JMO Ferrozine (colorimetric)... · Chemistry
May 2000 53d
MAGNETIC TIBC KIT
K990216 · JMO Ferrozine (colorimetric)... · Chemistry
Feb 1999 25d
RDI DIRECT LDL CHOLESTEROL TEST
K984107 · MRR System, Test, Low... · Chemistry
Jan 1999 72d
RDI HOMOGENEOUS HDL CHOLESTEROL TEST
K973988 · LBS Ldl & Vldl Precipitation,... · Chemistry
Dec 1997 62d
RDI LDL PRECIPITATION REAGENT
K964063 · MRR System, Test, Low... · Chemistry
Nov 1996 41d
RDI LIPIDIRECT MAGNETIC LDL REAGENT
K964064 · MRR System, Test, Low... · Chemistry
Nov 1996 41d
MAGNETIC HDL CHOLESTEROL TEST
K944975 · LBR Ldl & Vldl Precipitation,... · Chemistry
Aug 1995 295d
MAGNETIC HDL CHOLESTEROL TEST
K911906 · LBR Ldl & Vldl Precipitation,... · Chemistry
Jul 1991 79d
LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES
K893740 · MRR System, Test, Low... · Chemistry
Mar 1990 306d
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