BION EBV-G (VCA) TEST SYSTEM— 510(k) K891785

Substantially Equivalent

Bion Ent., Ltd.

FDA 510(k) clearance K891785 for BION EBV-G (VCA) TEST SYSTEM, Substantially Equivalent on 1989-08-31. Applicant: Bion Ent., Ltd.. Device class: 1.

Clearance details

Applicant: Bion Ent., Ltd.
Product code: Code JRY
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1989-03-24
Decision date: 1989-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park Ridge, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JRY

K042118 — ATHENA MULTI-LYTE EBV IGG TEST SYSTEM2005-04-29
K900974 — INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.1990-04-16
K884829 — EBV EARLY ANTIGEN (R+D)1989-04-12
K822734 — EBV IGM TEST1982-12-09
K822985 — EBV-M KIT1982-12-03

More clearances from Bion Ent., Ltd.

K926066 — BION MUMPS-G ANTIBODY TEST SYSTEM1993-06-15
K901054 — BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE1990-04-05
K894622 — VARICELLA ZOSTER VIRUS1989-10-24
K894623 — RESPIRATORY SYNCYTIAL VIRUS1989-10-16
K894624 — MUMPS VIRUS1989-10-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.