BION MUMPS-G ANTIBODY TEST SYSTEM— 510(k) K926066

Name: FDA 510(k) clearance K926066
Creator: U.S. Food and Drug Administration
Published: 1993-06-15

Substantially Equivalent

Bion Ent., Ltd.

FDA 510(k) clearance K926066 for BION MUMPS-G ANTIBODY TEST SYSTEM, Substantially Equivalent on 1993-06-15. Applicant: Bion Ent., Ltd.. Device class: 2.

Clearance details

Applicant: Bion Ent., Ltd.
Product code: Code CAR
Device class: Class 2
Regulation: 21 CFR 880.2460
Advisory panel: General Hospital
Date received: 1992-12-01
Decision date: 1993-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park Ridge, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAR

view all

K920740 — EPISENSOR PLUS1994-03-07
K915577 — IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE1992-03-11

More clearances from Bion Ent., Ltd.

view all

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
K894626 — EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN1989-10-16

Recalls naming K926066

K-number listed on FDA's recall record

Z-1479-2013 — Plastic bottle containing 3.5 mL of IgG FITC 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 K926066.

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