Clinical Data, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
37
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K071706ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)December 20, 2007
K052591NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KITFebruary 9, 2006
K033983VITALAB IRON REAGENTMay 21, 2004
K040631VITALAB DIRECT BILIRUBIN REAGENTMarch 18, 2004
K040534VITALAB AMYLASE REAGENTMarch 11, 2004
K034000VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATORMarch 10, 2004
K040467VITALAB URIC ACID REAGENTMarch 8, 2004
K040508VITALAB MAGNESIUM REAGENTMarch 8, 2004
K031042ATAC HEMOGLOBIN A1C REAGENT KITNovember 3, 2003
K031044ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATORJuly 15, 2003
K030528ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)June 17, 2003
K863904DISPOSABLE ECG MONITORING ELECTRODEJanuary 6, 1987
K860046DETERMINATION OF PHENOBARBITALJanuary 22, 1986
K860045DETERMINATION OF GENTAMICINJanuary 22, 1986
K860049DETERMINATION OF QUINIDINEJanuary 22, 1986
K860047DETERMINATION OF CARBAMAZEPINEJanuary 22, 1986
K860048DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN)January 22, 1986
K854186IN VITRO TEST DETERMINATION OF SGPT(ALT)December 25, 1985
K854183IN VITRO TEST DETERMINATION OF THEOPHYLLINEDecember 19, 1985
K854184IN-VITRO TEST DETERMINATION OF TOBRAMYCINDecember 4, 1985