MUMPS VIRUS— 510(k) K894624

Substantially Equivalent

Bion Ent., Ltd.

FDA 510(k) clearance K894624 for MUMPS VIRUS, Substantially Equivalent on 1989-10-16. Applicant: Bion Ent., Ltd.. Device class: 1.

Clearance details

Applicant: Bion Ent., Ltd.
Product code: Code GRA
Device class: Class 1
Regulation: 21 CFR 866.3380
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 GRA

K822826 — ANTIBODY TO MUMPS VIRUS IFA TEST1982-12-03
K770216 — VIRAL ANTISERA, FLUORESCEIN LABELED1977-03-01

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

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