Clinical Data, Inc.
Medical device manufacturer in Brea, CA.
37510(k) clearances
0PMA approvals
0recalls
Device types
- DRX Electrode, Electrocardiograph 3
- KNK Acid, Uric, Uricase (Colorimetric) 3
- JIY Photometric Method, Iron (Non-Heme) 2
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 2
- CIG Diazo Colorimetry, Bilirubin 2
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 1
- BZQ Monitor, Breathing Frequency 1
- CGA Glucose Oxidase, Glucose 1
- CGX Alkaline Picrate, Colorimetry, Creatinine 1
- CHH Enzymatic Esterase--Oxidase, Cholesterol 1
- JJQ Colorimeter, Photometer, Spectrophotometer… 1
- CIX Bromcresol Green Dye-Binding, Albumin 1
- DPS Electrocardiograph 1
- DSF Recorder, Paper Chart 1
- CIS Hydrazone Colorimetry, Ast/Sgot 1
- CEO Phosphomolybdate (Colorimetric), Inorganic… 1
- KLB Radioimmunoassay, Tobramycin 1
- KLS Enzyme Immunoassay, Theophylline 1
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 1
- LBS Ldl & Vldl Precipitation, Cholesterol Via… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K071706 | Envoy 500 HDL; Cholesterol Reagent Kit (Model# 55301), Calibrator Kit (Model# 55118)LBS · Traditional | 12/20/2007SE |
| K052591 | Nanopia Wide Range C-Reactive Protein (CRP) Reagent KitDCK · Traditional | 02/09/2006SE |
| K033983 | Vitalab Iron ReagentJIY · Traditional | 05/21/2004SE |
| K040631 | Vitalab Direct Bilirubin ReagentCIG · Traditional | 03/18/2004SE |
| K040534 | Vitalab Amylase ReagentJFJ · Traditional | 03/11/2004SE |
| K034000 | Vitalab Triglycerides Reagent and Vitalab CalibratorCDT · Traditional | 03/10/2004SE |
| K040508 | Vitalab Magnesium ReagentJGJ · Traditional | 03/08/2004SE |
| K040467 | Vitalab Uric Acid ReagentKNK · Traditional | 03/08/2004SE |
| K031042 | Atac Hemoglobin A1C Reagent KitLCP · Traditional | 11/03/2003SE |
| K031044 | Atac Pak Uric Acid Reagent and Atac CalibratorKNK · Traditional | 07/15/2003SE |
| K030528 | Atac Iron Reagent, Atac Tibc Column Kit and Iron Calibrator (500 Ug/Dl)JIY · Traditional | 06/17/2003SE |
| K863904 | Disposable ECG Monitoring ElectrodeDRX · Traditional | 01/06/1987SE |
| K860049 | Determination of QuinidineLBZ · Traditional | 01/22/1986SE |
| K860048 | Determination of Phenytoin (Diphenylhydantoin)DIP · Traditional | 01/22/1986SE |
| K860047 | Determination of CarbamazepineKLT · Traditional | 01/22/1986SE |
| K860046 | Determination of PhenobarbitalDLZ · Traditional | 01/22/1986SE |
| K860045 | Determination of GentamicinLCD · Traditional | 01/22/1986SE |
| K854186 | In Vitro Test Determination of Sgpt(Alt)CKA · Traditional | 12/25/1985SE |
| K854183 | In Vitro Test Determination of TheophyllineKLS · Traditional | 12/19/1985SE |
| K854184 | In-Vitro Test Determination of TobramycinKLB · Traditional | 12/04/1985SE |
| K854188 | In Vitro Test Determination of Inorganic PhosphoroCEO · Traditional | 11/25/1985SE |
| K854187 | In-Vitro Test Determination of Sgot (Ast)CIS · Traditional | 11/25/1985SE |
| K854185 | In-Vitro Test Determination of Uric AcidKNK · Traditional | 11/25/1985SE |
| K854182 | In-Vitro Test Determination of TrialycerideCDT · Traditional | 11/25/1985SE |
| K854181 | In-Vitro Test Determination of AlbuminCIX · Traditional | 11/25/1985SE |
| K854180 | In-Vitro Test Determination Total BilirubinCIG · Traditional | 11/25/1985SE |
| K854179 | In-Vitro Test for the Determination of CholesterolCHH · Traditional | 11/25/1985SE |
| K854178 | In-Vitro Test for the Determination of CreatinineCGX · Traditional | 11/25/1985SE |
| K854177 | In-Vitro Test for the Determination of GlucoseCGA · Traditional | 11/25/1985SE |
| K851889 | Centurion-Ii, Model 3103 Apnea/Brady Cardia TrachyBZQ · Traditional | 10/23/1985SE |
| K852441 | In Vitro Tests for Phosphatase & Blood NitrogenCJE · Traditional | 08/21/1985SE |
| K852177 | Foam ECG ElectrodesDRX · Traditional | 08/09/1985SE |
| K850392 | Intelligent Photometers MCP, Ifp, Isp, FPS, SPSJJQ · Traditional | 04/12/1985SE |
| K823529 | Full-Disclosure Ambulatory ECG SystemDPS · Traditional | 12/15/1982SE |
| K822432 | Centurion Chart RecorderDSF · Traditional | 11/01/1982SE |
| K821802 | Centurion Electrode BeltDRX · Traditional | 07/30/1982SE |
| K821721 | Clinical Data Apnea DetectorFLS · Traditional | 07/13/1982SE |