Clinical Data, Inc. - FDA 510(k) Cleared Devices
36
Total
36
Cleared
0
Denied
FDA 510(k) Regulatory Record - Clinical Data, Inc. Chemistry ✕
21 devices
Cleared
Dec 20, 2007
ENVOY 500 HDL
Chemistry
182d
Cleared
Feb 09, 2006
NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
Chemistry
141d
Cleared
May 21, 2004
VITALAB IRON REAGENT
Chemistry
150d
Cleared
Mar 18, 2004
VITALAB DIRECT BILIRUBIN REAGENT
Chemistry
8d
Cleared
Mar 11, 2004
VITALAB AMYLASE REAGENT
Chemistry
9d
Cleared
Mar 10, 2004
VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR
Chemistry
77d
Cleared
Mar 08, 2004
VITALAB URIC ACID REAGENT
Chemistry
13d
Cleared
Mar 08, 2004
VITALAB MAGNESIUM REAGENT
Chemistry
10d
Cleared
Nov 03, 2003
ATAC HEMOGLOBIN A1C REAGENT KIT
Chemistry
216d
Cleared
Dec 25, 1985
IN VITRO TEST DETERMINATION OF SGPT(ALT)
Chemistry
71d
Cleared
Nov 25, 1985
IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE
Chemistry
41d
Cleared
Nov 25, 1985
IN-VITRO TEST FOR THE DETERMINATION OF CREATININE
Chemistry
41d
Cleared
Nov 25, 1985
IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL
Chemistry
41d
Cleared
Nov 25, 1985
IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN
Chemistry
41d
Cleared
Nov 25, 1985
IN-VITRO TEST DETERMINATION OF ALBUMIN
Chemistry
41d
Cleared
Nov 25, 1985
IN-VITRO TEST DETERMINATION OF TRIALYCERIDE
Chemistry
41d
Cleared
Nov 25, 1985
IN-VITRO TEST DETERMINATION OF URIC ACID
Chemistry
41d
Cleared
Nov 25, 1985
IN-VITRO TEST DETERMINATION OF SGOT (AST)
Chemistry
41d
Cleared
Nov 25, 1985
IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO
Chemistry
41d
Cleared
Aug 21, 1985
IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN
Chemistry
72d
Cleared
Apr 12, 1985
INTELLIGENT PHOTOMETERS MCP, IFP, ISP, FPS, SPS
Chemistry
70d