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Bion Ent., Ltd.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K926066 BION MUMPS-G ANTIBODY TEST SYSTEMCAR1993-06-15 View
510(k) K901054 BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDELSR1990-04-05 View
510(k) K894622 VARICELLA ZOSTER VIRUSGQW1989-10-24 View
510(k) K894626 EPSTEIN-BARR VIRUS-NUCLEAR ANTIGENLLM1989-10-16 View
510(k) K894623 RESPIRATORY SYNCYTIAL VIRUSLKT1989-10-16 View
510(k) K894624 MUMPS VIRUSGRA1989-10-16 View
510(k) K891785 BION EBV-G (VCA) TEST SYSTEMJRY1989-08-31 View
510(k) K894625 CHLAMYDIA (LGV-1)LKI1989-08-15 View
510(k) K893240 BION EBV-M (VCA) TEST SYSTEMLJN1989-07-14 View
510(k) K890616 BION DIRECT IDENTIFICATION CONTROL SLIDELJG1989-02-17 View
510(k) K881261 BION HSV1-G OR HSV2-G TEST SYSTEMGQO1988-06-07 View
510(k) K880679 BION CMV-G TEST SYSTEMGQH1988-06-03 View
510(k) K872845 BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUMDHN1987-08-17 View
510(k) K800434 PORTABLE MEDICAL ULTRASOUND SCANNERIYO1980-04-10 View
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