Environmental Chemical Specialties

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K812635ANEMIA CONTROLOctober 2, 1981
K811810URIC ACID TESTJuly 15, 1981
K811811TDM ANTI-CONVULSANT CONTROL LEVELS I-IIJuly 10, 1981
K811809ANTI-ARRHYTHMIC CONTROL LEVELS I & IIJuly 10, 1981
K803089GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT)January 2, 1981
K792377CARCINOEMBRYONIC ANTIGEN (CEA) CONTROLSeptember 26, 1980
K801854SPINAL FLUID CONTROL(HUMAN)September 16, 1980
K801061TOTAL PROTEIN TESTJuly 21, 1980
K792376QUANTITATIVE CONTROL URINE II (HUMAN)December 6, 1979
K792375ELEVATED LIPID CONTROLDecember 6, 1979
K792374QUANTITATIVE CONTROL URINE I (HUMAN)December 6, 1979
K780173LYPOPROTEIN CHOLESTEROL TEST KITMay 3, 1978
K771067CHOLESTEROL KITJuly 21, 1977
K771068TRIGLYCERIDE KITJuly 12, 1977
K761320GLUCOSE KITJanuary 25, 1977