Home / Companies / United Biotech, Inc.

United Biotech, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
22
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K981573UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVESeptember 15, 1998
K973154UBI MAGIWEL MARIJUANA METABOLITESJuly 22, 1998
K973692UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVEFebruary 9, 1998
K973156UBI MAGIWEL COCAINE METABOLITESOctober 28, 1997
K973153UBI MAGIWEL AMPHETAMINE METABOLITESOctober 28, 1997
K973155UBI MAGIWEL OPIATE METABOLITESOctober 28, 1997
K962211UBI MAGIWEL THYROXINE (T4) QUANTITATIVEJuly 8, 1996
K961236UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVEMay 30, 1996
K951993UBI MAGIWEL FERRITIN QUANTITATIVEJuly 5, 1995
K924689UBI MAGIWEL(TM) HELICOBACTER PYLORI IGGAugust 10, 1993
K905473UBI MAGIWEL CORTISOL QUANTITATIVEJanuary 31, 1991
K910033UBI MAGIWEL(TM) ANA QUANTITATIVEJanuary 25, 1991
K902897UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVEJuly 16, 1990
K883399UBI MAGIWEL CMV IGG QUANTITATIVEMarch 27, 1989
K883355UBI MAGIWEL RF-IGM QUANTITATIVESeptember 7, 1988
K864174UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVEMarch 13, 1987
K863442UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVEFebruary 4, 1987
K864075UBI MAGIWEL(TM) PROLACTIN QUANTATIVEDecember 16, 1986
K864079UBI MAGIWEL(TM) TSH QUANTITATIVEDecember 16, 1986
K864142UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVEDecember 3, 1986