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Quantech , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K012943THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGEJanuary 18, 2002
K990258QUANTECH TOTAL B-HCG ASSAYDecember 21, 1999
K984433QUANTECH CK-MB ASSAYNovember 1, 1999