BION CMV-G TEST SYSTEM— 510(k) K880679

Substantially Equivalent

Bion Ent., Ltd.

FDA 510(k) clearance K880679 for BION CMV-G TEST SYSTEM, Substantially Equivalent on 1988-06-03. Applicant: Bion Ent., Ltd.. Device class: 2.

Clearance details

Applicant: Bion Ent., Ltd.
Product code: Code GQH
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1988-02-19
Decision date: 1988-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park Ridge, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GQH

K982311 — BARTELS CINAKIT CMV ANTIGENEMIA1998-12-14
K964875 — CMV ANTIGEN CONTROL SLIDES1997-03-18
K935809 — CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY1994-05-05
K882835 — INDIRECT FLUORESCENT ASSAY FOR (HCMV)1988-12-05
K882024 — FITC MURINE MONOCLONAL ANTI-CMV IGG1988-08-03

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

Recalls naming K880679

K-number listed on FDA's recall record

Z-1478-2013 — Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kitsClass III·Terminated·Bion Enterprises Ltd·20130123

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K880679.

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