Seracare Technology

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K993631QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2December 9, 1999
K992939QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3December 9, 1999
K993715QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3November 16, 1999
K992770QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3November 12, 1999
K992395URINE DRUG SCREENING CONTROLAugust 26, 1999