Becton Dickinson Advanced Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K935667QTEST(R) STREPApril 21, 1994
K931294IQ TUPTAKE ASSAYJuly 22, 1993
K931295IQ TT4 ASSAYJuly 20, 1993
K926356PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREGMarch 18, 1993
K925132BECTON DICKINSON THYROID STIMULATING HORMONE SYSTEDecember 28, 1992
K923673PRECISE STREP ASeptember 28, 1992
K923060IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAYSeptember 15, 1992
K914958RIATRAC PLUSMarch 18, 1992
K915197PRECISE TM HCGDecember 17, 1991
K915200PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LADecember 16, 1991