BION HSV1-G OR HSV2-G TEST SYSTEM— 510(k) K881261

Name: FDA 510(k) clearance K881261
Creator: U.S. Food and Drug Administration
Published: 1988-06-07

Substantially Equivalent

Bion Ent., Ltd.

FDA 510(k) clearance K881261 for BION HSV1-G OR HSV2-G TEST SYSTEM, Substantially Equivalent on 1988-06-07. Applicant: Bion Ent., Ltd.. Device class: 2.

Clearance details

Applicant: Bion Ent., Ltd.
Product code: Code GQO
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 1988-03-24
Decision date: 1988-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park Ridge, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GQO

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K883281 — VIRGO HSV-2 IGG ELISA1989-03-10
K883282 — VIRGO HSV-1 IGG ELISA1989-03-10
K875366 — THE DDI SERODOT HERPES IGG TEST KIT1988-05-23
K871426 — VIROGEN HSV ANTIBODY TEST1987-10-15
K861120 — THE GOLDEN QUAD TEST (HSV)1987-02-02

More clearances from Bion Ent., Ltd.

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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 K881261

K-number listed on FDA's recall record

Z-1477-2013 — Plastic bottle containing 10.5 mL of IgG 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 K881261.

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