Medical Device Manufacturer · US , Mchenry , IL

Clinical Data, Inc.

36 submissions · 36 cleared · Since 1982
36
Total
36
Cleared
0
Denied

Clinical Data, Inc. — FDA 510(k) Submissions

Clinical Data, Inc. has submitted 36 FDA 510(k) premarket notifications since 1982, of which 36 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Acid, Uric, Uricase (colorimetric), Electrode, Electrocardiograph, Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides, Diazo Colorimetry, Bilirubin, Recorder, Paper Chart . Use the specialty filter in the sidebar to narrow results.

36 devices
1–25 of 36
ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)
K071706 · LBS Ldl & Vldl Precipitation,... · Chemistry
Dec 2007 182d
NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
K052591 · DCK C-reactive Protein,... · Chemistry
Feb 2006 141d
VITALAB IRON REAGENT
K033983 · JIY Photometric Method, Iron... · Chemistry
May 2004 150d
VITALAB DIRECT BILIRUBIN REAGENT
K040631 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Mar 2004 8d
VITALAB AMYLASE REAGENT
K040534 · JFJ Catalytic Methods, Amylase · Chemistry
Mar 2004 9d
VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR
K034000 · CDT Lipase... · Chemistry
Mar 2004 77d
VITALAB URIC ACID REAGENT
K040467 · KNK Acid, Uric, Uricase... · Chemistry
Mar 2004 13d
VITALAB MAGNESIUM REAGENT
K040508 · JGJ Photometric Method,... · Chemistry
Mar 2004 10d
ATAC HEMOGLOBIN A1C REAGENT KIT
K031042 · LCP Assay, Glycosylated... · Chemistry
Nov 2003 216d
ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
K031044 · KNK Acid, Uric, Uricase... · Toxicology
Jul 2003 105d
DISPOSABLE ECG MONITORING ELECTRODE
K863904 · DRX Electrode,... · Cardiovascular
Jan 1987 91d
DETERMINATION OF GENTAMICIN
K860045 · LCD Enzyme Immunoassay,... · Toxicology
Jan 1986 16d
DETERMINATION OF PHENOBARBITAL
K860046 · DLZ Enzyme Immunoassay,... · Toxicology
Jan 1986 16d
DETERMINATION OF CARBAMAZEPINE
K860047 · KLT Enzyme Immunoassay,... · Toxicology
Jan 1986 16d
DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN)
K860048 · DIP Enzyme Immunoassay,... · Toxicology
Jan 1986 16d
DETERMINATION OF QUINIDINE
K860049 · LBZ Enzyme Immunoassay,... · Toxicology
Jan 1986 16d
IN VITRO TEST DETERMINATION OF SGPT(ALT)
K854186 · CKA Nadh Oxidation/nad... · Chemistry
Dec 1985 71d
IN VITRO TEST DETERMINATION OF THEOPHYLLINE
K854183 · KLS Enzyme Immunoassay,... · Toxicology
Dec 1985 65d
IN-VITRO TEST DETERMINATION OF TOBRAMYCIN
K854184 · KLB Radioimmunoassay, Tobramycin · Toxicology
Dec 1985 50d
IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE
K854177 · CGA Glucose Oxidase, Glucose · Chemistry
Nov 1985 41d
IN-VITRO TEST FOR THE DETERMINATION OF CREATININE
K854178 · CGX Alkaline Picrate,... · Chemistry
Nov 1985 41d
IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL
K854179 · CHH Enzymatic... · Chemistry
Nov 1985 41d
IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN
K854180 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Nov 1985 41d
IN-VITRO TEST DETERMINATION OF ALBUMIN
K854181 · CIX Bromcresol Green... · Chemistry
Nov 1985 41d
IN-VITRO TEST DETERMINATION OF TRIALYCERIDE
K854182 · CDT Lipase... · Chemistry
Nov 1985 41d
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