Bion Ent., Ltd.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K926066BION MUMPS-G ANTIBODY TEST SYSTEMJune 15, 1993
K901054BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDEApril 5, 1990
K894622VARICELLA ZOSTER VIRUSOctober 24, 1989
K894624MUMPS VIRUSOctober 16, 1989
K894626EPSTEIN-BARR VIRUS-NUCLEAR ANTIGENOctober 16, 1989
K894623RESPIRATORY SYNCYTIAL VIRUSOctober 16, 1989
K891785BION EBV-G (VCA) TEST SYSTEMAugust 31, 1989
K894625CHLAMYDIA (LGV-1)August 15, 1989
K893240BION EBV-M (VCA) TEST SYSTEMJuly 14, 1989
K890616BION DIRECT IDENTIFICATION CONTROL SLIDEFebruary 17, 1989
K881261BION HSV1-G OR HSV2-G TEST SYSTEMJune 7, 1988
K880679BION CMV-G TEST SYSTEMJune 3, 1988
K872845BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUMAugust 17, 1987
K800434PORTABLE MEDICAL ULTRASOUND SCANNERApril 10, 1980