Princeton Biomedix

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K942052LIFESIGN MI MYOGLOBINFebruary 7, 1995
K925355BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TESTJuly 12, 1994
K930185OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEPMarch 4, 1993
K925183BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TESTFebruary 23, 1993
K926308LIFESIGN HCG - ONE STEP HOME PREGNANCY TESTJanuary 26, 1993
K901011BIOSIGN HCG-ONE STEP PREGNANCY TESTMay 4, 1990
K894705BIOSPOT HCG-RAPID PREGNANCY TESTOctober 18, 1989
K894750BIOSTIX I. HCG - ONE STEP PREGNANCY TESTOctober 18, 1989
K892654BIOSTIX (TM)HCG--SIMPLE PREGNANCY TESTJune 19, 1989
K761315ALKALINE PHOSPHATASE (ALP)/PNPPFebruary 24, 1977
K760346ASSAY FOR GAMMA GLUTAMYLTRANSFERASEOctober 27, 1976
K760345TEST, LACTATE DEHYDROGENASEOctober 27, 1976
K760347SET, TRINDER GLUCOSEOctober 5, 1976
K760161TEST, ACID PHOSPHATASEJuly 20, 1976