Home / Companies / Dade Chemistry Systems, Inc.

Dade Chemistry Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K973650TROPONIN (TROP) METHODOctober 20, 1997
K973100PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATORSeptember 29, 1997
K973099PROSTATE SPECIFIC ANTIGEN CONTROLSeptember 29, 1997
K973101PROSTATE SPECIFIC ANTIGEN METHODSeptember 18, 1997
K971141FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEMApril 28, 1997
K970387HUMAN CHORIONIC GONADOTROPIN METHODMarch 10, 1997
K970336MMB CALIBRATORMarch 3, 1997
K970393THYROID STIMULATING HORMONE METHODMarch 3, 1997
K970396HUMAN CHORIONIC GONADOTROPIN CALIBRATORFebruary 20, 1997
K970389THYROID CALIBRATORFebruary 18, 1997
K970343MMB METHODFebruary 14, 1997
K963498FERR FLEX REAGENT CARTRIDGEJanuary 24, 1997
K963493FERRITIN CALIBRATORDecember 3, 1996