Clinical Data, Inc.

FDA 510(k) & PMA Approved Devices — 36 products

Total Devices36

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K071706	ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)	LBS	2007-12-20	View
510(k)	K052591	NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT	DCK	2006-02-09	View
510(k)	K033983	VITALAB IRON REAGENT	JIY	2004-05-21	View
510(k)	K040631	VITALAB DIRECT BILIRUBIN REAGENT	CIG	2004-03-18	View
510(k)	K040534	VITALAB AMYLASE REAGENT	JFJ	2004-03-11	View
510(k)	K034000	VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR	CDT	2004-03-10	View
510(k)	K040508	VITALAB MAGNESIUM REAGENT	JGJ	2004-03-08	View
510(k)	K040467	VITALAB URIC ACID REAGENT	KNK	2004-03-08	View
510(k)	K031042	ATAC HEMOGLOBIN A1C REAGENT KIT	LCP	2003-11-03	View
510(k)	K031044	ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR	KNK	2003-07-15	View
510(k)	K863904	DISPOSABLE ECG MONITORING ELECTRODE	DRX	1987-01-06	View
510(k)	K860049	DETERMINATION OF QUINIDINE	LBZ	1986-01-22	View
510(k)	K860046	DETERMINATION OF PHENOBARBITAL	DLZ	1986-01-22	View
510(k)	K860048	DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN)	DIP	1986-01-22	View
510(k)	K860047	DETERMINATION OF CARBAMAZEPINE	KLT	1986-01-22	View
510(k)	K860045	DETERMINATION OF GENTAMICIN	LCD	1986-01-22	View
510(k)	K854186	IN VITRO TEST DETERMINATION OF SGPT(ALT)	CKA	1985-12-25	View
510(k)	K854183	IN VITRO TEST DETERMINATION OF THEOPHYLLINE	KLS	1985-12-19	View
510(k)	K854184	IN-VITRO TEST DETERMINATION OF TOBRAMYCIN	KLB	1985-12-04	View
510(k)	K854182	IN-VITRO TEST DETERMINATION OF TRIALYCERIDE	CDT	1985-11-25	View