Clinical Data, Inc.
Brea, CA, US
Clinical Data, Inc. appears in FDA device records in Brea, CA. FDA records list 37 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 37
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 37 510(k) clearances for Clinical Data, Inc. between 1982 and 2007. The busiest year on record is 1985, with 16. The most recent is 2007, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 4 |
| 1985 | 16 |
| 1986 | 5 |
| 1987 | 1 |
| 2003 | 3 |
| 2004 | 6 |
| 2006 | 1 |
| 2007 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K071706 | ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) | LBS | Substantially Equivalent | |
| K052591 | NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT | DCK | Substantially Equivalent | |
| K033983 | VITALAB IRON REAGENT | JIY | Substantially Equivalent | |
| K040631 | VITALAB DIRECT BILIRUBIN REAGENT | CIG | Substantially Equivalent | |
| K040534 | VITALAB AMYLASE REAGENT | JFJ | Substantially Equivalent | |
| K034000 | VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR | CDT | Substantially Equivalent | |
| K040508 | VITALAB MAGNESIUM REAGENT | JGJ | Substantially Equivalent | |
| K040467 | VITALAB URIC ACID REAGENT | KNK | Substantially Equivalent | |
| K031042 | ATAC HEMOGLOBIN A1C REAGENT KIT | LCP | Substantially Equivalent | |
| K031044 | ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR | KNK | Substantially Equivalent | |
| K030528 | ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) | JIY | Substantially Equivalent | |
| K863904 | DISPOSABLE ECG MONITORING ELECTRODE | DRX | Substantially Equivalent | |
| K860049 | DETERMINATION OF QUINIDINE | LBZ | Substantially Equivalent | |
| K860048 | DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN) | DIP | Substantially Equivalent | |
| K860047 | DETERMINATION OF CARBAMAZEPINE | KLT | Substantially Equivalent | |
| K860046 | DETERMINATION OF PHENOBARBITAL | DLZ | Substantially Equivalent | |
| K860045 | DETERMINATION OF GENTAMICIN | LCD | Substantially Equivalent | |
| K854186 | IN VITRO TEST DETERMINATION OF SGPT(ALT) | CKA | Substantially Equivalent | |
| K854183 | IN VITRO TEST DETERMINATION OF THEOPHYLLINE | KLS | Substantially Equivalent | |
| K854184 | IN-VITRO TEST DETERMINATION OF TOBRAMYCIN | KLB | Substantially Equivalent | |
| K854188 | IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO | CEO | Substantially Equivalent | |
| K854187 | IN-VITRO TEST DETERMINATION OF SGOT (AST) | CIS | Substantially Equivalent | |
| K854185 | IN-VITRO TEST DETERMINATION OF URIC ACID | KNK | Substantially Equivalent | |
| K854182 | IN-VITRO TEST DETERMINATION OF TRIALYCERIDE | CDT | Substantially Equivalent | |
| K854181 | IN-VITRO TEST DETERMINATION OF ALBUMIN | CIX | Substantially Equivalent | |
| K854180 | IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN | CIG | Substantially Equivalent | |
| K854179 | IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL | CHH | Substantially Equivalent | |
| K854178 | IN-VITRO TEST FOR THE DETERMINATION OF CREATININE | CGX | Substantially Equivalent | |
| K854177 | IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE | CGA | Substantially Equivalent | |
| K851889 | CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY | BZQ | Substantially Equivalent | |
| K852441 | IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN | CJE | Substantially Equivalent | |
| K852177 | FOAM ECG ELECTRODES | DRX | Substantially Equivalent | |
| K850392 | INTELLIGENT PHOTOMETERS MCP, IFP, ISP, FPS, SPS | JJQ | Substantially Equivalent | |
| K823529 | FULL-DISCLOSURE AMBULATORY ECG SYSTEM | DPS | Substantially Equivalent | |
| K822432 | CENTURION CHART RECORDER | DSF | Substantially Equivalent | |
| K821802 | CENTURION ELECTRODE BELT | DRX | Substantially Equivalent | |
| K821721 | CLINICAL DATA APNEA DETECTOR | FLS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- LCPAssay, Glycosylated Hemoglobin
- CIXBromcresol Green Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JFJCatalytic Methods, Amylase
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- CIGDiazo Colorimetry, Bilirubin
- DPSElectrocardiograph
- DRXElectrode, Electrocardiograph
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- KLTEnzyme Immunoassay, Carbamazepine
- DIPEnzyme Immunoassay, Diphenylhydantoin
- LCDEnzyme Immunoassay, Gentamicin
- DLZEnzyme Immunoassay, Phenobarbital
- LBZEnzyme Immunoassay, Quinidine
- KLSEnzyme Immunoassay, Theophylline
- CGAGlucose Oxidase, Glucose
- CISHydrazone Colorimetry, Ast/Sgot
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- FLSMonitor, Apnea, Facility Use
- BZQMonitor, Breathing Frequency
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- JGJPhotometric Method, Magnesium
- KLBRadioimmunoassay, Tobramycin
- DSFRecorder, Paper Chart
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain