Derma Media Lab., Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K970664GLUCOSE REAGENTAugust 1, 1997
K971309UREAAugust 1, 1997
K971072CHOLESTEROL REAGENTJune 20, 1997
K970867URIC ACID REAGENTApril 21, 1997
K971005TRIGLYCERIDESApril 21, 1997
K964915MAGNESIUMMarch 26, 1997
K964913IRON REAGENTFebruary 20, 1997
K965134ALT/SGPTFebruary 18, 1997
K964914ALKALINE PHOSPHATASEFebruary 4, 1997
K965126AST/SGOTJanuary 17, 1997
K964916GAMMA-GLUTAMYL TRANSPEPTIDASEJanuary 10, 1997
K964912LACTATE DEHYDROGENASEJanuary 9, 1997
K955939CALCIUM REAGENTMarch 13, 1996
K955781ALBUMINMarch 13, 1996
K955940TOTAL BILIRUBIN REAGENTMarch 13, 1996
K955938CREATININE REAGENTMarch 12, 1996
K955936TOTAL PROTEIN REAGENTMarch 12, 1996
K955937INORGANIC PHOSPHORUS REAGENTMarch 12, 1996