Cleared Traditional

BION MUMPS-G ANTIBODY TEST SYSTEM

K926066 · Bion Ent., Ltd. · Microbiology

Jun 1993

Decision

196d

Days

Class 2

Risk

About This 510(k) Submission

K926066 is an FDA 510(k) clearance for the BION MUMPS-G ANTIBODY TEST SYSTEM, a Monitor, Spinal-fluid Pressure, Electrically Powered (Class II — Special Controls, product code CAR), submitted by Bion Ent., Ltd. (Park Ridge, US). The FDA issued a Cleared decision on June 15, 1993, 196 days after receiving the submission on December 1, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 880.2460.

Submission Details

510(k) Number	K926066 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 01, 1992
Decision Date	June 15, 1993
Days to Decision	196 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF