Company ยท US
Clinical Data, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 2007. Name variants (Inc, Corp, punctuation) are merged.
37510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DRX | Electrode, Electrocardiograph | 3 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 3 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 |
| CIG | Diazo Colorimetry, Bilirubin | 2 |
| JIY | Photometric Method, Iron (Non-Heme) | 2 |
| BZQ | Monitor, Breathing Frequency | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIS | Hydrazone Colorimetry, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
| DIP | Enzyme Immunoassay, Diphenylhydantoin | 1 |
| DLZ | Enzyme Immunoassay, Phenobarbital | 1 |
| DPS | Electrocardiograph | 1 |
| DSF | Recorder, Paper Chart | 1 |
| FLS | Monitor, Apnea, Facility Use | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 20, 2007 | K071706 | ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) Clinical Data, Inc. | LBS |
| Feb 9, 2006 | K052591 | NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT Clinical Data, Inc. | DCK |
| May 21, 2004 | K033983 | VITALAB IRON REAGENT Clinical Data, Inc. | JIY |
| Mar 18, 2004 | K040631 | VITALAB DIRECT BILIRUBIN REAGENT Clinical Data, Inc. | CIG |
| Mar 11, 2004 | K040534 | VITALAB AMYLASE REAGENT Clinical Data, Inc. | JFJ |
| Mar 10, 2004 | K034000 | VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR Clinical Data, Inc. | CDT |
| Mar 8, 2004 | K040508 | VITALAB MAGNESIUM REAGENT Clinical Data, Inc. | JGJ |
| Mar 8, 2004 | K040467 | VITALAB URIC ACID REAGENT Clinical Data, Inc. | KNK |
| Nov 3, 2003 | K031042 | ATAC HEMOGLOBIN A1C REAGENT KIT Clinical Data, Inc. | LCP |
| Jul 15, 2003 | K031044 | ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR Clinical Data, Inc. | KNK |
| Jun 17, 2003 | K030528 | ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) Clinical Data | JIY |
| Jan 6, 1987 | K863904 | DISPOSABLE ECG MONITORING ELECTRODE Clinical Data, Inc. | DRX |
| Jan 22, 1986 | K860049 | DETERMINATION OF QUINIDINE Clinical Data, Inc. | LBZ |
| Jan 22, 1986 | K860048 | DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN) Clinical Data, Inc. | DIP |
| Jan 22, 1986 | K860047 | DETERMINATION OF CARBAMAZEPINE Clinical Data, Inc. | KLT |
| Jan 22, 1986 | K860046 | DETERMINATION OF PHENOBARBITAL Clinical Data, Inc. | DLZ |
| Jan 22, 1986 | K860045 | DETERMINATION OF GENTAMICIN Clinical Data, Inc. | LCD |
| Dec 25, 1985 | K854186 | IN VITRO TEST DETERMINATION OF SGPT(ALT) Clinical Data, Inc. | CKA |
| Dec 19, 1985 | K854183 | IN VITRO TEST DETERMINATION OF THEOPHYLLINE Clinical Data, Inc. | KLS |
| Dec 4, 1985 | K854184 | IN-VITRO TEST DETERMINATION OF TOBRAMYCIN Clinical Data, Inc. | KLB |
| Nov 25, 1985 | K854188 | IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO Clinical Data, Inc. | CEO |
| Nov 25, 1985 | K854187 | IN-VITRO TEST DETERMINATION OF SGOT (AST) Clinical Data, Inc. | CIS |
| Nov 25, 1985 | K854185 | IN-VITRO TEST DETERMINATION OF URIC ACID Clinical Data, Inc. | KNK |
| Nov 25, 1985 | K854182 | IN-VITRO TEST DETERMINATION OF TRIALYCERIDE Clinical Data, Inc. | CDT |
| Nov 25, 1985 | K854181 | IN-VITRO TEST DETERMINATION OF ALBUMIN Clinical Data, Inc. | CIX |
| Nov 25, 1985 | K854180 | IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN Clinical Data, Inc. | CIG |
| Nov 25, 1985 | K854179 | IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL Clinical Data, Inc. | CHH |
| Nov 25, 1985 | K854178 | IN-VITRO TEST FOR THE DETERMINATION OF CREATININE Clinical Data, Inc. | CGX |
| Nov 25, 1985 | K854177 | IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE Clinical Data, Inc. | CGA |
| Oct 23, 1985 | K851889 | CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY Clinical Data, Inc. | BZQ |
| Aug 21, 1985 | K852441 | IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN Clinical Data, Inc. | CJE |
| Aug 9, 1985 | K852177 | FOAM ECG ELECTRODES Clinical Data, Inc. | DRX |
| Apr 12, 1985 | K850392 | INTELLIGENT PHOTOMETERS MCP, IFP, ISP, FPS, SPS Clinical Data, Inc. | JJQ |
| Dec 15, 1982 | K823529 | FULL-DISCLOSURE AMBULATORY ECG SYSTEM Clinical Data, Inc. | DPS |
| Nov 1, 1982 | K822432 | CENTURION CHART RECORDER Clinical Data, Inc. | DSF |
| Jul 30, 1982 | K821802 | CENTURION ELECTRODE BELT Clinical Data, Inc. | DRX |
| Jul 13, 1982 | K821721 | CLINICAL DATA APNEA DETECTOR Clinical Data, Inc. | FLS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||