RESPIRATORY SYNCYTIAL VIRUS— 510(k) K894623

Substantially Equivalent

Bion Ent., Ltd.

FDA 510(k) clearance K894623 for RESPIRATORY SYNCYTIAL VIRUS, Substantially Equivalent on 1989-10-16. Applicant: Bion Ent., Ltd.. Device class: 1.

Clearance details

Applicant: Bion Ent., Ltd.
Product code: Code LKT
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 1989-07-20
Decision date: 1989-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park Ridge, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LKT

K081928 — D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT2008-12-23
K983336 — PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP11999-03-18
K943317 — PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)1994-12-19
K942173 — RSV ANTIGEN TEST1994-06-30
K912842 — RSV-MAB TEST1991-12-09

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
K894624 — MUMPS VIRUS1989-10-16
K894626 — EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN1989-10-16

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